View list of clinical trials including ethnopharmacological

NUCLEUS NETWORK LIMITED Clinical Trials List

www.nucleusnetwork.com.au

EARLY PHASE STUDIES

Sponsor Compound Type

No of Subjects

Route of Administration

Study Description Therapeutic Area Type of Subjects

US Biotech New Formulation

18 Oral A Double Blind Randomized Parallel Group Study to Evaluate the Tolerability of a New Extended Release (ER) Capsules in Healthy Elderly Volunteers

Neuroprotective - Alzhiemier's Disease

Healthy subjects

US Biotech New Chemical Entity

20 Oral A phase 1 Study in Subjects with Well Controlled Coeliac Disease to Assess the Effects of Gluten Digestion with a Protease Enzyme in Vitro.

Coeliac Disease Patients

US Big Pharma New Biological 6 SC Injection A Randomised, Double-blind, Placebo-Controlled, Multiple dose Study to Evaluate the Safety, Tolerability and Efficiency of a New Biological in Subjects with Psoriasis.

Dermatology- Psoriasis

Patients

US Big Pharma New Biological 72 SC Injection A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Biological in Healthy Subjects and Subjects with Moderate to Severe Psoriasis

Dermatology - Psoriasis

Healthy subjects

US Big Pharma New Biological 6 SC Injection A Long-term Assessment of the Safety and Efficacy of a New Biological Subcutaneous Treatment in Subjects with Psoriasis


Patients

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EARLY PHASE STUDIES

US Big Pharma New Biological 20 SC Injection A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of a New Biological After Multiple Dose Administration in Subjects with Moderate to Severe Psoriasis.


Patients

US Big Pharma New Chemical Entity

40 Oral A Phase I, Randomized, Open-Label, Single-Dose, 2-Part, 4-Treatment, 4-Way Crossover Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics of Various Formulations When Administered Under Fasted and Fed Conditions

Asthma Healthy subjects

US Big Pharma New Biological 72 SC Injection A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Biological in Healthy Subjects and Subjects with Moderate to Severe Psoriasis


Healthy subjects

US Big Pharma New Biological 4 SC Injection A Long-term Assessment of the Safety and Efficacy of a New Biological Subcutaneous Treatment in Subjects with Psoriasis


Patients

US Biotech Existing Chemical Entity

30 Topical A Phase I/II Pilot Single Ascending-Dose, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Two Topically Applied Gel Formulations in Patients with Postherpetic Neuralgia

Allodynic Pain Patients

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EARLY PHASE STUDIES

Australian Biotech

Existing Chemical Entity

16 Oral A Comparative Pharmacokinetic Study of a Single Oral Dose of an Anti-depressant Compared with a Deuterated Analogue in Healthy Volunteers.

CNS - Depression Healthy subjects

Big Pharma New Chemical Entity

60 Oral Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral formulations in patients with Symptomatic Pulmonary Arterial Hypertension (PAH) Study

Cardiovascular- Respiratory

Patients


60 Oral Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national, Study to Evaluate the Efficacy and Safety of oral formulations in patients with Chronic Thromboembolic Pulmonary Hypertension


Patients


60 Oral Randomized, Double-blind, Placebo-controlled, Multi-centre, Multi-national, Study to Evaluate the Efficacy and Safety of Oral Formulations in Patients with Symptomatic Pulmonary Arterial Hypertension


Patients


60 Oral Long-term Extension, Multi-centre, Multi-national Study to Evaluate the Safety and Tolerability of Oral Formulations in Patients with Chronic Thromboembolic Pulmonary Hypertension


Patients

EU Big Pharma Existing Chemical Entity

20 Oral A Randomized,Double-Blind, 2-way Crossover, Placebo-Controlled Study to Investigate the Influence of a Single-Dose of Moxifloxacin on the QTc Interval in Healthy Male and Female Subjects for Positive Control Validation of a Parallel Patient Study

Pulmonary Arterial Hyprtension

Healthy subjects

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EARLY PHASE STUDIES

Australian Biotech

New Chemical Entity

1 IV Infusion A Phase 1, Two-Stage, Dose-Escalation Study of a Novel Vascular Disrupting Agent in Patients with Advanced Solid Tumours

Oncology Patients

Australian Biotech

New Chemical Entity

72 Oral A Phase I, Single-Centre, Double-Blind, Placebo-Controlled, Escalating Single Oral Dose, Safety and Tolerability Clinical Trial with a New Chemical Entity in Healthy Subjects

Respiratory Syncytial Virus

Healthy subjects

Australian Biotech

New Chemical Entity

40 Oral Suspension A Phase I, Single-Centre, Placebo Controlled, Dose-Escalating Study of the Safety and Pharmacokinetics of a New Chemical Entity in Healthy Male Volunteers Administered Orally in the Fasted and Fed State

Hepatitis C Healthy subjects

EU Big Pharma New Chemical Entity

32 Oral Safety, Antiviral Effect and Pharmacokinetics of a New Chemical Entity inCombination with Another New Chemical Entity and with Ribavirin for 4 (Part 1) and with or without Ribavirin for 24-48 weeks (Part 2) in patients with Chronic HCV genotype 1 infection (randomized, open label, Phase II)

Hepatitis C Patients

US Big Pharma New Formulation

128 Oral Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a New Formulation and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males

Anti-Inflammatory Patients

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EARLY PHASE STUDIES

US Big Pharma Phase I (not FTIH)

24 Oral Suspension A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety Pharmacokinetics and Pharmacodynamics of a Compound in Healthy Subjects

Cardiovascular – Lipid lowering

Healthy subjects

US Big Pharma New Biological 5 Oral A Phase 1 Multiple Ascending Dose Study of a New Biological in Subjects with Advanced Metastatic Solid Tumours.

Oncology Patients


56 Oral Suspension Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of a New Chemical Entity in Healthy Subjects

Cardiovascular - Cholesterol reduction

Healthy subjects


104 Oral A placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Chemical Entity in Healthy Volunteers

Rheumatology Healthy subjects


40 Oral Suspension A Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a New Chemical Entity in Healthy Male Subjects.

Diabetes Healthy subjects


40 Oral Suspension A Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of a Compound in Healthy Subjects

Cardiovascular – Lipid lowering

Healthy subjects

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EARLY PHASE STUDIES


56 Oral A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Chemical Entity in Healthy Subjects

Oncology Healthy subjects


40 Oral Suspension Randomized, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a New Chemical Entity in Healthy Male Subjects.


US Big Pharma New Biological 5 Oral Phase 1 Multiple Ascending Dose Study of a New Biological in Subjects with Advanced Metastatic Solid Tumours.

Oncology Patients


40 Oral Suspension Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of an Oral Suspension in Healthy Subjects

Cardiovascular - cholesterol reducing

Healthy subjects

US Biotech New Transdermal Drug Delivery System

20 Transdermal A Phase 1 Study to Evaluate the Pharmacokinetics and Safety During Treatment with a 7-Day Patch, Delivery System (TDS), and Branded Capsules for 7 Days in Healthy Male Volunteers.

Urology Healthy subjects

US Biotech New Transdermal Drug Delivery System

16 Transdermal Phase 1 Study to Evaluate the Pharmacokinetics and Safety of a Hormone administered via a Transdermal Delivery System and Subcutaneous Injection in Healthy Female Volunteers

Rheumatology - Osteoporosis

Healthy subjects

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EARLY PHASE STUDIES

Australian Biotech

New Chemical Entity

9 IV infusion A Prospective Single Arm, Two Stage, Open-Label, Phase II trial of a New Chemical Entity in Relapsed and Refractory Multiple Myeloma.

Oncology Patients


8 Oral A Phase 1b, Open Label Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Chemical Entity Administered Orally Twice a Day for 28 days Immediately Prior to Initiation of Treatment with HCV Standard of Care Therapy in Treatment-Naïve Subjects Chronically Infected with HCV.


US Big Pharma New Biological 20 IV Infusion A Safety, Tolerability and Efficacy Study of an Intravenous Compound in Subjects with Rheumatoid Arthritis Receiving Background Oral DMARDs.

Rheumatoid Arthritis

Patients

US Big Pharma New Biological 72 SC Injection Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New Biological After Multiple Subcutaneous Injections in Subjects with Type 2 Diabetes.


Australia Biotech


24 Inhaled A Phase I, Clinical Trial to Determine the Pharmacokinetics of a Reproductive Hormone and Ethinyl Estradiol Following Transdermal Application with a Metered Dose Transdermal Applicator

Reproduction - Menopause

Healthy subjects

China Biotech New Chemical Entity

24 SC Injection A Phase 1, Open Labelled, Dose Escalation Trial in Healthy Subjects to Examine the Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose of a New Chemical Entity

Haematology Healthy subjects

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EARLY PHASE STUDIES

US Biotech/Pharma

Phase I (not FTIH)

36 Inhaled A Phase I, Randomised, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of an Inhalation Compound in Healthy Volunteers

Respiratory - Cystic Fibrosis

Healthy subjects

US Biotech/Pharma

New Chemical Entity

12 Inhaled A Phase I Randomised, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of a New Chemical Entity in Subjects with Cystic Fibrosis (CF)

Respiratory- Cystic Fibrosis

Patients

US Biotech/Pharma

Phase I (not FTIH)

12 Inhaled A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Compound in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Respiratory - COPD Patients

US Biotech/Pharma

New Chemical Entity

12 Inhaled A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety and Tolerability of a New Chemical Entity in Healthy Male Volunteers


Healthy subjects

US Biotech/Pharma

New Chemical Entity

15 Inhaled A Phase 1 Randomised, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a chemical entity in Healthy Male Volunteers


Healthy subjects

EU Big Pharma Phase I (not FTIH)

24 Oral A Phase I, Randomized, Single-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics , and Pharmacodynamics of Repeat Oral Doses of a new chemical entity in Healthy Subjects

Haematology - Anaemia

Healthy subjects

EU Big Pharma New Biological 36 IV Infusion A Randomised, Double-blind, Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety,

Neurology - Multiple Sclerosis

Patients

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EARLY PHASE STUDIES

Tolerability and Pharmacokinetics of a New Biological Administered by Intravenous (IV) Infusion to Patients with Relapsing Forms of Multiple Sclerosis, not on Disease Modifying Therapy


42 Oral A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Food Effect of Single Oral Doses of an Inhibitor, in Healthy Subjects

Oncology Healthy subjects

EU Big Pharma New Biological 6 IV Infusion A Randomised, Single-blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of a New Biologic in Patients with Alzheimer’s Disease

Neurology - Alzheimers Disease

Patients


4 Intravenous A Randomized, Double-Blind, Placebo-Controlled, Bayesian Adaptive Dose Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Intravenous Infusions of a Chemical Entity in Patients with Active Rheumatoid Arthritis (RA).

Rheumatology Patients

EU Big Pharma Monoclonal Antibody

9 IV Infusion Clinical Phase I/IIA Study of Subcutaneous Administration of a Monoclonal Antibody in Rheumatoid Arthritis Patients on Stable Dose Methotrexate

Rheumatology Patients

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EARLY PHASE STUDIES

EU Big Pharma New Biological 6 IV Infusion A Randomised, Single-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of a New Biological in Patients with Alzheimer’s Disease

Neurology - Alzheimers Disease

Patients

EU Big Pharma FTIH 12 A Phase I, Open-Label Two-Stage Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Oral AKT Inhibitor in Subjects with Haematologic Malignancy

Oncology Patients

EU Big Pharma Phase I (not PTIH)

Oral A Phase I Open label Dose Escalation Study of an Inhibitor in Subjects with Solid Tumours

Oncology Patients

Australian Biotech


15 Topical A Phase I/IIa Study to Determine the Safety, Tolerability and Absorption of a Lotion Administered Topically to the Hair and Scalp of Subjects with Head Lice

Anti-bacterial - Head Lice

Patients

China Biotech New Biological 40 Oral Suspension A Phase 1 Randomized, Double-Blinded ,Placebo Controlled Trial in Healthy Male Volunteers to Examine the Safety, Tolerability, and Pharmacokinetics of a New Biological After a Single Dose


China Biotech Phase I (not FTIH)

24 Oral A Phase 1, randomized, double-blind, placebo-controlled trial in healthy male volunteers to examine the safety, tolerability and pharmacokinetics of a compound after multiple dosing for 14 days


US Biotech New Biological 36 IV Infusion A Randomized, Double-Blind, Placebo-Controlled, MultiCenter Study of a new biological to Evaluate Safety,

Cardiovascular - CABG

Patients

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EARLY PHASE STUDIES

Pharmacokinetics and Proof-Of-Concept Efficacy for Reduction of Ischemia-Reperfusion Mediated Cardiac Injury in Participants Undergoing Coronary Artery Bypass Graft (CABG) Surgery


32 IV Infusion A Phase I, Randomised, Single-Blind, Placebo-Controlled, Single-Center, Dose Escalation Study of a Bolus Injection of a New Chemical Entity

Cardiovascular Healthy subjects


21 IV Infusion A Phase I, Single-Center, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Tolerability, Safety and Pharmacokinetics of a Single Intravenous Infusion of a New Chemical Entity Administered to Healthy Adult Male Volunteers



56 IV Infusion A Double-Blind, Randomized, Placebo Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of a New Chemical Entity in Healthy Male Volunteers

Renal Healthy subjects


16 IV Infusion A Double-Blind, Randomized, Placebo-Controlled, Two Period Crossover Study to Assess the Safety and Tolerability of Single Ascending Doses of a New Chemical Entity in Haemodialysis Subjects with Secondary Hyperparathyroidism

Renal Patients

US Biotech New Biological 12 SC Injection A Phase 1 Randomised Double-Blind, Placebo-Controlled, Single Dose, Dose Escalation Study of a rheumatology compound in Healthy Male Volunteers.


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EARLY PHASE STUDIES


62 Oral A Single Centre, Open-Label Phase 1 study to Investigate the Safety, Tolerability and Pharmacokinetcs of Five Sequential Single Doses Followed by Three Sequential Multiple Dose Regimens of a New Oral Chemical Entity in Healthy Male Subjects.

Transplantation Healthy subjects


40 Oral Suspension A Randomized, Double-Blind, Placebo-Controlled Phase 1 Studyto Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of a New Chemical Entity Given With or Without Tacrolimus in Healthy Male Subjects



40 Oral Suspension A Single-Centre, Randomized, Double-Blind, Placebo-Controlled Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of a New Chemical Entity Given With or Without Tacrolimus in Healthy Male Subjects and Male Subjects with Metabolic Syndrome


US Big Pharma New Vaccine 30 SC A Phase IIa Randomised Double-Blinded, Clinical Trial to Study the Tolerability and Immunogenicity of a Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Healthy 16-26 -Year –Old Women

Human Papilloma Virus

Healthy subjects

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EARLY PHASE STUDIES

New Zealand Biotech

New Formulation

40 IV Infusion A Phase 1, Double-Blind, Randomized, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of a New Formulation in Healthy Female Subjects, When Administered as Loading Dose(10-minute infusion), and as a Loading Dose Followed by a Maintanance Dose(72-hour infusion)

Neurology Healthy subjects

Australian Biotech

New Vaccine 18 SC Injection A Phase I Study to Determine Safety, Tolerability and Bioactivity of a New Vaccine in HLA DQ2+ Volunteers with Coeliac Disease Following a Long-term, Strict Gluten-free Diet

Coeliac disease Patients

US Big Pharma Existing Chemical Entity

24 Oral An Open-Label, Randomized, 2-way, Cross-Over Study, to Assess Potential Drug- Drug interactions in healthy adult subjects


US Big Pharma New Biological ?? Intravenous A Phase 1, Randomised, Placebo-controlled, Double Blind, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Intravenous Dose of a New Biologic in Patients with Mild-to-Moderate Alzheimer's disease.

Alzheimer's Disease

Patients

US Big Pharma New Biological 5 IV Infusion A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability and Pharmacokinetics of Multiple Doses of a New Biological in Patients with Mild to Moderate Alzheimer's Disease.

Alzheimer's Disease

Patients

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EARLY PHASE STUDIES


39 IV Infusion A Phase 1, Open Label, Single-Center, Dose-Escalation Study to Determine the Safety, Pharmacodynamics and Pharmacokinetics of a Single Intravenous (IV) Injection of a New Chemical Entity in Healthy Subjects

Anaesthesia Healthy subjects

US Biotech/Pharma

New Chemical Entity

80 Oral A Phase 1, Single-Centre, Dose-Escalation and Fixed-Dose Crossover, Cohort Study to Determine the Safety and Pharmacokinetics of a Single Oral Dose of a New Chemical Entity in Healthy Subjects

Pain Healthy subjects


20 A Multicenter, Randomized, Pilot Phase 1 Study to Evaluate the Combination of an HCV Polymerase Inhibitor and HCV Protease Inhibitor in Genotype 1 Chronic Hepatitis C Patients


EU Big Pharma New Biological 10 IV Infusion A Randomised Double-Blind, Multiple-Ascending Dose, Placebo-Controlled, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Biological following Intravenous Infusion in Healthy Volunteers and Patients with Peripheral Arterial Disease.

Vascular - Peripheral Arterial Disease

Patients


15 Oral Multicenter, Randomized, Pilot Phase 1 Study to Evaluate the Combination of a New Chemical Entity in Genotype 1 Chronic Hepatitis C Patients


EU Big Pharma New Formulation

32 Oral Relative Bioavailability of Four Prototype Formulations in Comparison to the Reference Phase 1 Capsule Formulation, after Single Oral Administration under


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EARLY PHASE STUDIES

Fasting and Fed Conditions to Healthy Male Subjects.

US Big Pharma Existing Chemical Entity

24 IV Infusion A Rising Single Dose and Multiple-Dose Tolerability, Safety and Pharmacokinetic Study of an Intravenous Compound in Healthy Volunteers and Patients with Psoriasis


Healthy subjects

US Big Pharma New Formulation

32 SC Injection A Single Dose Safety and Tolerability Placebo Controlled Study of Subcutaneous New Formulation in Healthy Volunteers


Healthy subjects


23 Oral A Study to Further Understand the Effects of a new chemical entity on Tissue Neutrophils

Respiratory - COPD Healthy subjects


24 SC Injection A Rising Single-dose and Multiple-dose Safety, Tolerability and Pharmacokinetic Study of a New Chemical Entity in Healthy Volunteers and Subjects with Rheumatoid Arthritis


EU Big Pharma New Formulation

36 Oral A Comparative Pharmacokinetic Study of Strontium after Single Oral Administration of Three Different Salts of a New Formulation. An Open Parallel Randomised Study Performed in 3 groups of 12 Young Healthy Male Volunteers

Postmenopausal osteoarthritis

Healthy subjects

EU Big Pharma Phase I (not FTIH)

16 Oral A Pilot Single Dose Study to Compare the In-Vivo Release Profiles from Three Fixed Combination Tablets, Varying by their In-Vitro Release Rates, with the Free Combination Formulation, and an Oral Solution. Single dose, Open-label, Modified Randomised (five-period) Four-way


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EARLY PHASE STUDIES

Crossover Study in Healthy Male VolunteersEU Pharma New Chemical

Entity32 Oral A Phase I, Pharmacokinetic Trial, in Healthy Asian and

Caucasian Volunteers for Investigating the Pharmacokinetic Profiles of a New Chemical Entity for Malaria

Infectious Diseases - Anti-parasitic

Healthy subjects(Caucasian and Asian)

Australian Biotech

New Chemical Entity

36 Oral A Phase I, Randomized, Double-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Compound Following Single Ascending Oral Dosing of the New Compound in Healthy Volunteers Administered in the Fasted and Fed State

Pain Healthy subjects

Australia Biotech

New Chemical Entity

12 Vaginal Gel Assessment of Local Retention and Duration of Activity of a Gel Following Vaginal Application in Healthy Female Volunteers

Infectious Disease -HIV

Healthy subjects

Taiwanese Biotech

Herbal Medicine

60 Oral Evaluation of the Efficacy of a Chinese Herbal Medicine in the Treatment of Patients with Osteoarthritis of the Knee

Osteoarthritis Patients

US Biotech ???? ??? ??? A Randomised, Placebo-Controlled Trial of a chemical entity in Patients With Insulin-Dependent Type 1 Diabetes and Microalbuminuria

Diabetes Patients

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EARLY PHASE STUDIES

Japan Big Pharma


260 Oral A Randomized, Double-blind, Placebo- and Positive-controlled, Parallel Study to Evaluate the Effect of a compound on the QT/QTc Interval in Healthy Adult Male and Female Subjects

Endocrine - Diabetes

Healthy subjects

US Big Pharma New Biological 5 IV Infusion A Phase 3, Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel-Group Efficacy and Safety Trial of a New Chemical Entity in Subjects with Mild to Moderate Alzheimer Disease who are Apolipoprotein E ε4 Non-Carriers.

Neurology- Alzheimer's Disease

Patients

US Big Pharma New Biological 5 IV Infusion A Phase 3, Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel-Group Efficacy and Safety Trial of a New Biological in Subjects with Mild to Moderate Alzheimer Disease who are Apolipoprotein E ε4 Carriers.

Neurology - Alzheimer's Disease

Patients

US Big Pharma New Vaccine 80 IM A Phase I Trial Evaluating the Safety, Tolerability and Immunogenicity of 3 Ascending Dose Levels of a Staphylococcus Aureus Vaccine in Healthy Adults

Infectious Disease Healthy subjects

US Big Pharma New Biological 5 IV Infusion A Phase 3, Multicentre, Randomised, Double Blind, Placebo Controlled, Parallel-Group Efficacy and Safety Trial of a New Biological in Subjects with Mild to Moderate Alzheimer Disease who are Apolipoprotein E ε4 Non-Carriers.

Neurology-Alzheimer's Disease

Patients


50 IV Infusion A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a New

Obesity Patients

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EARLY PHASE STUDIES

Chemical Entity in Obese Volunteers

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EARLY PHASE STUDIES

ETHNIC STUDIES

Sponsor Compound Type

No of Subjects

Route of Administration

Study Description Therapeutic Area Type of Subjects


32 Oral Influence of Race/Ethnic Origin on the Pharmacokinetics of a new chemical entity

Neurology Healthy subjects


32 Oral Influence of Race/Ethnic Origin on the Pharmacokinetics of a New Chemical Entity

Respiratory - COPD Healthy Japanese, Chinese and Causasian Subjects

US Biotech Existing Chemical Entity

24 Oral A Single-Dose, Open-Label, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of an Oral Formulation in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

Multiple Sclerosis Healthy subjects

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Business

View list of clinical trials including ethnopharmacological