Clinical trials: Safety and Tolerability in Healthy Volunteers
Type 2 Diabetes Mellitus (T2DM)
A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
- Trial name
- NCT05761301
- Testing
- ALN-KHK
- Where
- 15 sites in United States, Canada
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Oral Ulcer, Oral Mucositis
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
The goal of this clinical trial is to learn if a new 1% Phenytoin mucoadhesive film is safe and works to treat oral ulcers in healthy adult volunteers and patients with oral ulcers.
- Conditions
- Oral Ulcer, Oral Mucositis, Aphthous Stomatitis
- Trial name
- PHENO-FILM (NCT07890428)
- Testing
- 1% Phenytoin Mucoadhesive Film, Blank Mucoadhesive Film
- Where
- Egypt
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Misr University for Science and Technology
Healthy Volunteers
Phase I Clinical Study of MWN109 Tablets in Healthy Chinese Participants
This is a randomized, double-blind, placebo-controlled, Phase 1 clinical study conducted in China to evaluate the safety, tolerability, pharmacokinetic (PK), and the effect of meal timing following single and multiple oral doses…
- Trial name
- NCT07787611
- Testing
- MWN109 tablet
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
Pulmonary Fibrosis, Tumor
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of 9MW3811 in Healthy Subjects
This is a first-in-human, single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
- Trial name
- NCT05740475
- Testing
- 9MW3811 injection
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Major Depressive Disorder, Recurrent, Unspecified
Multiple Ascending Dose Study in Healthy Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY03005
Objectives To evaluate the safety and tolerability of escalating multiple oral doses of LY03005 in healthy subjects. To characterize the pharmacokinetics of escalating multiple oral doses of LY03005.
- Trial name
- NCT02271412
- Testing
- LY03005
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Luye Pharma Group Ltd.
Cough
The Safety, Tolerability, PK and PD of GSK2339345 in Healthy Subjects
This is a First Time in Human (FTIH) study for the sodium channel inhibitor, GSK2339345. The study is split into two parts. Part A will assess the safety and tolerability of the new drug.
- Trial name
- FTIH (NCT01494636)
- Testing
- GSK2339345 (solution), GSK2339345 (nebulised), Lidocaine
- Where
- United Kingdom
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Male Volunteers
Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs
drug-drug interaction between DWP14012 and three different kinds of NSAIDs
- Trial name
- NCT04490434
- Testing
- DWP14012, Celecoxib, Naproxen
- Where
- South Korea
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
A Randomized Phase 1 of of MZE001 in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single (SAD) / multiple (MAD) ascending dose and food effect study.
- Trial name
- NCT05249621
- Testing
- MZE001
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Maze Therapeutics
Chronic Obstructive Pulmonary Disease
A Study to Assess Safety, Tolerability and Pharmacokinetics of of AZD6553 in Healthy Volunteers and Patients With Chronic Obstructive Pulmonary Disease (COPD)
AZD6553 is a new drug being developed as a possible treatment for patients with chronic obstructive pulmonary disease (COPD). COPD refers to chronic bronchitis and emphysema, a pair of two commonly co-existing diseases of the…
- Trial name
- NCT01068184
- Testing
- AZD6553
- Where
- United Kingdom
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Safety Issues, Tolerance
Study to Assess the Safety, Tolerability and Pharmacokinetics of ZX-7101A and the Food Effect in Healthy Volunteers
Randomized, double-blind and placebo-controled study to assess the safety, tolerability and pharmacokinetics of single ascending doses of ZX-7101A and its food effect in China healthy adult volunteers.
- Conditions
- Safety Issues, Tolerance, Pharmacokinetics, Food Effect
- Trial name
- NCT05217732
- Testing
- ZX-7101A
- Where
- China
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Nanjing Zenshine Pharmaceuticals
Healthy Volunteers
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability…
- Trial name
- NCT04746287
- Testing
- CKD-510 single dose, CKD-510 food effect, CKD-510 multiple dose
- Where
- France
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
Psoriasis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Moderate to Severe Psoriasis
The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).
- Trial name
- NCT01094093
- Testing
- AMG 139
- Where
- 4 sites in Australia, New Zealand
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Acne Vulgaris
A Phase 1, 3 Day Study of Safety and Tolerability of NVN1000 Topical Gel in Healthy Volunteers
A Phase I, Single-Center, Open-Label, Randomized, Parallel Group, 3 Day Study Evaluating the Safety and Cutaneous Tolerability of NVN1000 Topical Gel in Healthy Volunteers
- Trial name
- NCT01755247
- Testing
- Topical Gel Vehicle, 8% NVN1000 Topical Gel, 8% NVN1000 Topical Gel and moisturizer
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Novan, Inc.
Acne Vulgaris
A Safety, Tolerability, Efficacy and Exposure Study of XEN801 Topical Gel
Phase 1/2 study enrolling up to 60 healthy volunteers in Phase 1 followed by approximately 150 subjects with acne vulgaris in Phase 2.
- Trial name
- NCT02656043
- Testing
- XPF-005
- Where
- 20 sites in Canada
- Volunteers
- 213 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.
Group B Streptococcal Infections
Phase I/II Study to a Assess the GBS-06 Vaccine Manufactured by Inventprise, Inc., in Healthy, Non-Pregnant, Adult Women of Childbearing Age.
To assess the safety and tolerability of IVT GBS-06 vaccine administered as a single-dose regimen, at three dosage levels in healthy, non-pregnant, adult women of childbearing age (WOCBA).
- Trial name
- NCT06611371
- Testing
- IVT GBS-06
- Where
- 2 sites in United States, South Africa
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Inventprise Inc.
Dose Finding Study
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants
The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.
- Trial name
- NCT02706834
- Testing
- TAK-828
- Where
- 2 sites in United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Participants Study
Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
To evaluate the tolerability and safety of a single oral dose of ZL-65 tablets in healthy adult trial participants through dose escalation; and to preliminarily assess the pharmacokinetic and pharmacodynamic characteristics of a…
- Trial name
- NCT07757152
- Testing
- This group of participants take ZL-65 tablet
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
Healthy
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of PF-06649751 Co-administered With Trimethobenzamide Hydrochloride in Healthy Subjects
This study will test the hypothesis that PF-06649751 with continuous co-administration of trimethobenzamide hydrochloride (TMB) with will be safe and well tolerated.
- Trial name
- NCT02262767
- Testing
- PF-06649751, Trimethobenzamide Hydrochloride
- Where
- 2 sites in Belgium
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Pfizer
Drug Safety
Ascending Single-Dose and Multiple-Dose Study to Evaluate RJ4287 in Healthy Subjects
A Randomized Study of RJ4287 Drug to Evaluate the Safety, Tolerability, Pharmacokinetics and Food-effect of Single and Multiple Doses in Healthy Volunteers
- Trial name
- NCT05921006
- Testing
- RJ4287
- Where
- China
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- Nanjing Ruijie Pharma Co., Ltd.
Alcohol Use Disorder
A First in Human Study of CMND-100 in Healthy and Alcohol Use Disorder (AUD) Subjects
The primary objective of this study is to find the tolerable dose and characterize the safety and pharmacokinetics/ pharmacodynamics (PK/PD) of single and repeated dose of CMND-100 in Healthy Volunteers (HV) and Subjects with…
- Trial name
- NCT05913752
- Testing
- CMND-100
- Where
- 4 sites in United States, Israel
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Clearmind Medicine Inc.
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