Clinical trials: Tolerability
Healthy Subjects
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2609 in Healthy Adult Male Japanese and White Subjects
This study is primarily designed to bridge the pharmacokinetics (PK) and safety data for E2609 between Japanese subjects and non-Japanese (ie, white) subjects.
- Trial name
- NCT02207790
- Testing
- E2609
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Eisai Inc.
Pneumococcal Infections
Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025)
This study will evaluate the safety and tolerability and immunogenicity of V114 when administered to 2-month old infants. The primary hypotheses are: 1) V114 is non-inferior to Prevenar 13™ for the 13 shared serotypes between…
- Trial name
- PNEU-PED-EU-1 (NCT04031846)
- Testing
- Rotarix™, Infanrix™ hexa, V114
- Where
- 60 sites in Australia, Belgium and 7 more
- Volunteers
- 1,184 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Endometriosis
BAY2328065 Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Relative Bioavailability, Food Effect
This single center, double-blind, randomized study with up to 11 treatment groups evaluates the safety and tolerability, pharmacokinetics, relative bioavailability and food effect of single ascending doses of BAY2328065
- Trial name
- NCT03427788
- Testing
- BAY2328065
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Bayer
Skin Aging
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the…
- Trial name
- XEO-001/07 (NCT00986570)
- Testing
- Botulinum Toxin A
- Where
- Brazil
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Biolab Sanus Farmaceutica
Pneumococcal Infection
Safety and Immunogenicity of V116 in Adults With Increased Risk for Pneumococcal Disease (V116-008)
The primary objectives of this study are to evaluate the safety and tolerability of the pneumococcal 21 valent conjugate vaccine (V116), and to evaluate the serotype-specific opsonophagocytic activity (OPA) post-vaccination with…
- Trial name
- STRIDE-8 (NCT05696080)
- Testing
- V116, PCV15, PPSV23
- Where
- 44 sites in United States, Australia and 6 more
- Volunteers
- 518 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Adult Volunteers
Study of VSA001 Injection in Chinese Healthy Adult Volunteers
This is a phase 1, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics effects of a single dose of VSA001 injection in Chinese healthy…
- Trial name
- NCT05757596
- Testing
- VSA001 injection
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Visirna Therapeutics HK Limited
Healthy
A Clinical Study of MK-7962 in Healthy Chinese Participants (MK-7962-021)
The goal of this study is to learn about the safety of 2 different amounts of sotatercept and if healthy Chinese people tolerate them.
- Trial name
- NCT06843460
- Testing
- Sotatercept
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Type 2 Diabetes
The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers
SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia.
- Trial name
- SHR3824 (NCT02356224)
- Testing
- SHR3824
- Where
- China
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Filariasis
Relative Bioavailability Study of Emodepside IR-tablets and Solution
This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they will be compared to the oral liquid service formulation (LSF) used in the FIH Single Ascending Dose study (DNDi-EMO-001 study) (CT.gov…
- Trial name
- NCT03383523
- Testing
- Emodepside (BAY 44-4400)
- Where
- United Kingdom
- Volunteers
- 77 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Healthy Participants
Study of BLU-808 in Healthy Adult Participants
This is a 3-part study. Parts 1 and 2 are randomized, double-blind, placebo-controlled investigations of single ascending doses (SAD) (Part 1) and multiple ascending doses (MAD) (Part 2) of orally administered BLU-808 in healthy…
- Trial name
- NCT06948032
- Testing
- BLU-808, Midazolam
- Where
- United States
- Volunteers
- 95 people, healthy volunteers welcome
- Sponsor
- Blueprint Medicines Corporation
HIV Infections
Evaluate Tolerability of a Multi-envelope, Prime-boost HIV Vaccine in Healthy Adults
Vaccines have been very successful in preventing viral infections such as hepatitis B and the measles. Viral vaccines work by causing a person's immune system to make cells that will work against the virus.
- Trial name
- NCT00623753
- Testing
- EnvDNA, PolyEnv1, EnvPro
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital
Healthy Volunteer
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Healthy Volunteers
This is a Phase 1, randomized, double-blind, placebo-controlled, single-ascending dose study in healthy volunteers, enrolled at a single site in the United States to investigate the safety, tolerability, and pharmacokinetics of…
- Trial name
- NCT02596399
- Testing
- DSTA4637S
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy Volunteer
A Phase 1 SAD/MAD Study of RLS-0071 in Healthy Volunteers in Support of a COVID-19 Development Program
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety, tolerability, PK, and PD of single- and multiple-ascending doses of RLS-0071 in healthy adult subjects.
- Trial name
- NCT05298787
- Testing
- RLS-0071
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ReAlta Life Sciences, Inc.
Complicated Urinary Tract Infections(cUTI)
Evaluation of the Safety, Tolerability and Pharmacokinetics of TUL108 for Injection in Healthy Participants (SAD/ MAD)
To evaluate the safety, tolerability and pharmacokinetics of single and multiple intravenous (IV) infusion of TUL108 in healthy participants.
- Trial name
- NCT07719257
- Testing
- TUL108
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Health Volunteer
Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration
- Trial name
- NCT07101965
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Rosacea
A Study to Evaluate the Safety, Tolerability, and Effects of Anatabloc® Crème in Rosacea
This is a multi-site, four-visit, eight-week, double-blind, randomized, vehicle-controlled, parallel-group study followed by an eight-week open-label extension to evaluate the safety, tolerability, and potential effects of…
- Trial name
- NCT01740934
- Testing
- Anatabloc Cream
- Where
- 3 sites in United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Rock Creek Pharmaceuticals, Inc.
Respiratory Syncytial Virus
A Study to Assess the Safety, Tolerability, and Immunogenicity of RSVpreF in Older Adults in Korea
The goal of this clinical trial is to quantify the immune response in older Korean adults after a RSVpreF vaccination. It will also learn about the safety and tolerability of RSVpreF vaccination.
- Trial name
- NCT06593587
- Testing
- RSVpreF Vaccine
- Where
- 16 sites in South Korea
- Volunteers
- 378 people, healthy volunteers welcome
- Sponsor
- Pfizer
Endometriosis Related Pain, Overactive Bladder
Study on the Safety of Drug BAY1817080 at Different Doses and the Way the Body Absorbs and Eliminates the Drug in Japanese Healthy Adult Male Participants
Researchers in this study want to learn about the safety of drug BAY1817080 at different doses and the resulting blood levels of the study drug in Japanese healthy adult male participants.
- Conditions
- Endometriosis Related Pain, Overactive Bladder, Diabetic Neuropathic Pain, Refractory or Unexplained Chronic Cough
- Trial name
- NCT04265781
- Testing
- BAY1817080
- Where
- Japan
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Obstructive Pulmonary Disease
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Nebulized Ensifentrine in Healthy Chinese Subjects
This is a phase 1, open-label, parallel cohort study to evaluate the PK, safety and tolerability of nebulized ensifentrine following administration of single and multiple doses in healthy Chinese male subjects.
- Trial name
- NCT05758428
- Testing
- Ensifentrine
- Where
- China
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Nuance Pharma (shanghai) Co., Ltd
MELAS Syndrome, Mitochondrial Respiratory Chain Deficiencies
Safety, Tolerability and Pharmacokinetic Study of KL1333 in Healthy Male Volunteers
The purpose of this First In Human study is to investigate the safety and tolerability of KL1333 after a single oral dose and to investigate the pharmacokinetic characteristics of KL1333 after a single oral dose.
- Trial name
- NCT03056209
- Testing
- KL1333 25 mg, KL1333 50 mg, KL1333 100 mg
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Yungjin Pharm. Co., Ltd.
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