Clinical trials: Normal Healthy Volunteers
Herpes Simplex
A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI).
- Trial name
- NCT05298254
- Testing
- Non-adjuvanted HSV formulation 1, Non-adjuvanted HSV formulation 2, Non-adjuvanted HSV formulation 3
- Where
- 30 sites in United States, Australia and 6 more
- Volunteers
- 505 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hereditary Angioedema
A Relative Bioavailability Study of Two Formulations of BCX7353
This is an open-label, randomized study to investigate the relative bioavailability of two formulations of BCX7353 and to determine if there is a food effect
- Trial name
- NCT03202784
- Testing
- BCX7353
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- BioCryst Pharmaceuticals
Psoriasis
Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects
It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male…
- Trial name
- NCT04371185
- Testing
- BAT2206, Stelara(US-licensed), Stelara(EU-licensed)
- Where
- China
- Volunteers
- 270 people, healthy volunteers welcome
- Sponsor
- Bio-Thera Solutions
Breast Cancer, Healthy Volunteers
Study to Determine Absorption, Metabolism, and Excretion of [14C]-SAR439859, and to Assess Absolute Oral Bioavailability of Amcenestrant (SAR439859), in Healthy Post-menopausal Women
Primary Objectives: To assess the excretion balance after oral and IV administration of [14C]-SAR439859 To assess PK of total radioactivity, [14C] -SAR439859 and its metabolite (M7) after IV administration of [14C]-SAR439859 and…
- Trial name
- NCT04940026
- Testing
- amcenestrant, [14C]-SAR439859 microtracer, [14C]-SAR439859
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Sanofi
Bioavailability of ASP015K, Pharmacokinetics of ASP015K
A Single Oral Dose Study of ASP015K in Healthy Volunteers Assessing the Relative Bioavailability Across Three Tablet Strengths From a New Formulation of ASP015K
The purpose of this study is to determine the relative bioavailability and pharmacokinetic profiles from three strengths of a new tablet formulation of ASP015K and to evaluate the safety and tolerability after a single dose of…
- Conditions
- Bioavailability of ASP015K, Pharmacokinetics of ASP015K, Healthy Subjects
- Trial name
- NCT01486017
- Testing
- ASP015K
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Healthy
Metformin ER 750 mg Tablets, Fed
The objective of this study is to compare the rate and extent of absorption of metformin from a test formulation of Metformin ER 750 mg Tablets versus the reference Glucophage® XR 750 mg Tablets under fed conditions.
- Trial name
- NCT00834613
- Testing
- Glucophage® XR 750 mg Tablets, Metformin ER 750 mg Tablets
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Teva Pharmaceuticals USA
Breast Cancer
A Drug-Drug Interaction Study of Rifampicin and Oral HRS-8080
A single-center, single-arm, open-label, fixed-sequence study is planned to enroll 18 healthy participants (6-9 females). The study consists of a screening period, an observation period, and a safety follow-up period.
- Trial name
- NCT07876596
- Testing
- HRS-8080, Rifampicin
- Where
- China
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Healthy, Idiopathic Inflammatory Myopathies
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with autoimmune diseases.
- Conditions
- Healthy, Idiopathic Inflammatory Myopathies, Systemic Sclerosis, Sjögren's Disease
- Trial name
- NCT07284797
- Testing
- XmAb657
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
Diabetes Mellitus, Type 2, Healthy Volunteer
A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2104 in Normal Healthy Male Volunteers
The purpose of this study is to determine the safety and tolerability of SRT2104 (0.03, 0.1, 0.25, 0.5, 1.0, 2.0, and 3.0 g/day) in healthy male volunteers when administered after a single dose and once daily for 7 consecutive…
- Trial name
- NCT00933530
- Testing
- SRT2104
- Where
- United Kingdom
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Sirtris, a GSK Company
Cardiac Effects in Normal Healthy Volunteers
A Study to Evaluate the Effect of IV ACHN-490 Injection on the QT/QTc Interval in Healthy Volunteers
The purpose of this study is to determine if the study drug, ACHN-490 Injection, affects the QT interval in normal volunteers. The hypothesis is that the drug will not cause an increase in the QT interval.
- Trial name
- NCT01514929
- Testing
- ACHN-490 Injection, Moxifloxacin
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Achaogen, Inc.
Healthy Volunteers
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fed Condition
The objective of the study is to demonstrate bioequivalence between Test Product (A): Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding Reference Product (B): Prograf (Tacrolimus)…
- Trial name
- NCT01080534
- Testing
- Tacrolimus 5 mg Capsule
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Panacea Biotec Ltd
Endometriosis, Uterine Fibroids
A Trial of SHR7280 in Healthy Subjects
The study is being conducted to evaluate the effect of high-fat meal on pharmacokinetics of SHR7280 after oral administration and the effect of SHR7280 on QT interval at low and high doses in healthy Chinese volunteers.
- Conditions
- Endometriosis, Uterine Fibroids, Assisted Reproduction
- Trial name
- NCT06969664
- Testing
- SHR7280 Tablet
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Hereditary Angioedema (HAE)
A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects
The purpose of this study is to assess the safety and tolerability of the study drug (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to receive DX-2930 or placebo.
- Trial name
- NCT01923207
- Testing
- DX-2930
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shire
Sensitivity, Contact
Sensitization Study of ATx201 in Healthy Volunteers
This is a Phase I, single-site study to evaluate the sensitization potential of topically applied ATx201 GEL, 2% and 4%, along with a placebo control, in healthy human subjects.
- Trial name
- NCT03375957
- Testing
- ATx201
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- UNION therapeutics
Healthy
Microdialysis and Pharmacokinetic Study of TR-701
The purpose of this study is to measure the penetration of TR-700 into subcutaneous adipose tissue and skeletal muscle after a single oral dose of 600 mg TR-701
- Trial name
- NCT00666601
- Testing
- TR-700 (active moiety), TR-701 (pro-drug)
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Trius Therapeutics LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Hepatic Impairment
Study to Evaluate a Dose of Telotristat Etiprate in Male and Female With Mild, Moderate and Severe Hepatic Insufficiency and Matched Healthy Subjects
The purpose of the protocol is to assess the pharmacokinetics, safety and tolerability of a single dose of telotristat etiprate in subjects with various stages of hepatic impairment compared to healthy control subjects.
- Trial name
- NCT02683577
- Testing
- telotristat etiprate
- Where
- 2 sites in Moldova, Romania
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Ipsen
Renally Impaired Subjects
Single-dose Pharmacokinetics and Safety of Oral Lofexidine in Renally-Impaired Subjects
This is a phase 1, open-label, parallel-group, single-dose study of lofexidine in 8 adult subjects with ESRD maintained on hemodialysis (3 times per week) and 8 control subjects with normal renal function, recruited as 1:1…
- Trial name
- NCT02313103
- Testing
- lofexidine HCl
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- USWM, LLC (dba US WorldMeds)
Healthy Volunteer, Renal Impairment
Study of AT-527 in Subjects With Normal and Impaired Renal Function
Study of AT-527 in Subjects with Normal and Impaired Renal Function
- Trial name
- NCT05618314
- Testing
- AT-527, AT-527 and Probenecid
- Where
- Canada
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Diabetes Mellitus, Type 2
A Clinical Study to Assess the Safety and Pharmacokinetics of SRT2379 in Normal Healthy Male Volunteers
The main purpose of this study is to assess the safety and pharmacokinetics of SRT2379 (25, 75, 250, 500, 1000, 2000, and 3000 mg/day [fasted] and 500 mg/day [fed]) in healthy male volunteers.
- Trial name
- NCT01018628
- Testing
- SRT2379
- Where
- United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Breast Cancer
A Dose-Finding Study of Subcutaneous Herceptin (Trastuzumab) in Healthy Male Volunteers and Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Females
This two-part study is designed to select the subcutaneous (SC) dose of Herceptin that results in comparable exposure to intravenous (IV) Herceptin in healthy male participants and in HER2-positive female participants.
- Trial name
- NCT00800436
- Testing
- Herceptin
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche