Clinical trials: Tolerability
Healthy Volunteers
IPI-145 Single Ascending, Multiple Ascending, Food Effect and Drug-Drug-Interaction Study
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of IPI-145 after single and repeat oral administration, and to evaluate the effects of food and ketoconazole on the plasma…
- Trial name
- NCT01549106
- Testing
- IPI-145
- Where
- Netherlands
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- SecuraBio
Healthy
A Study in Healthy Men Tests How Different Doses of BI 764198 Are Taken up in the Body and How Well They Are Tolerated.
The main objective of this trial is to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single rising doses.
- Trial name
- NCT03854552
- Testing
- BI 764198
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Malaria,Falciparum
Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali
Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat…
- Trial name
- NCT06413108
- Testing
- TB31F, Normal saline
- Where
- Mali
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Healthy Adult Participants
A SINGLE CENTER, 5-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS
This first-in-human Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of GAL-101 salt following oral administration to healthy adult and elderly participants.
- Trial name
- GAL-101-C0102 (NCT07780604)
- Testing
- Uncoated GAL-101 Salt 1170 mg, Enteric-Coated Capsules 195 mg, Enteric-Coated Capsules 390 mg
- Where
- South Africa
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Galimedix Therapeutics Inc
Contraception
Casea S Contraceptive Implants (Casea S) Trial
This is a single-center, two-part, Phase 1 study to evaluate the pharmacokinetics (PK) of ENG, removability, safety, and tolerability of Casea S pellets inserted subdermally in healthy women of reproductive age.
- Trial name
- NCT05174884
- Testing
- 22.2 mg Etonogestrel (ENG), 44.4 mg Etonogestrel (ENG)
- Where
- Dominican Republic
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- FHI 360
Healthy
AZD9164 Single Ascending Dose Study in Healthy Male Subjects
The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.
- Trial name
- NCT00847249
- Testing
- AZD9164
- Where
- Sweden
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.
- Trial name
- NCT06326606
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Healthy
Pharmacokinetics and Safety/Tolerability Profiles of DA-2811 in Healthy Subjects (DA-2811)
This is the phase I study to evaluate the pharmacokinetics and safety of DA-2811 and DA-2811-R after a single oral dose in healthy volunteers.
- Trial name
- NCT04938752
- Testing
- DA-2811, DA-2811-R
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy Subjects
A Study of NBL-012 in Healthy Chinese Subjects
This is a phase 1, randomized, double-blind, placebo-controlled, sequential cohort study to evaluate the safety, tolerability and pharmacokinetics (PK) of NBL-012 as single ascending doses (SAD) administered subcutaneously to…
- Trial name
- NCT05259189
- Testing
- NBL-012 Injection
- Where
- China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- NovaRock Biotherapeutics, Ltd
Endometriosis
Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of BAY1128688 After Multiple Oral Administrations in Healthy Women
The objective of this trial is to investigate the safety and tolerability of BAY1128688 and to determine the concentration of this substance in blood after repeated administration by the oral route.
- Trial name
- NCT02434640
- Testing
- BAY1128688
- Where
- 3 sites in Germany
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- Bayer
Non-alcoholic Fatty Liver Disease
A Clinical Trial of XZP-6019 Tablets in Healthy Subjects
This study will consist of 3 parts: Part A - Single Ascending Dose (SAD) phase, Part B - Food Effect (FE) phase, and Part C - multiple ascending dose (MAD) phase.
- Trial name
- NCT05063968
- Testing
- XZP-6019 tablet
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
Healthy
A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants
Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.
- Trial name
- NCT00192348
- Testing
- CAIV-T
- Where
- Finland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Healthy Adult Male
Tegoprazan-Aspirin Drug Interaction in Healthy Adult Male Volunteers
This Clinical Trial Aims to Evaluate the PK/PD Drug-Drug Interaction and Safety/Tolerability of Tegoprazan and Aspirin in Healthy Adult Male Volunteers.
- Trial name
- NCT07853248
- Testing
- Aspirin, Tegoprazan, Tegoprazan + Aspirin
- Where
- South Korea
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Alzheimer Disease
Safety, Tolerability and Pharmacokinetics of CMS121, a Drug Candidate for Alzheimer's Disease, in Healthy Subjects
This is a randomized, double-blind study of CMS121 or placebo given as single and multiple escalating doses in normal healthy subjects.
- Trial name
- CMS121 (NCT05318040)
- Testing
- CMS121
- Where
- United States
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Virogenics, Inc.
Healthy Volunteers
Safety, Tolerability, and Pharmacokinetics of BGB-23339 in Healthy Japanese and Caucasian Subjects
This study is designed to evaluate the influence of ethnic factors on the safety, tolerability, and pharmacokinetics (PK) of BGB-23339 after multiple dosing under fasting condition in healthy Japanese and Caucasian participants.
- Trial name
- NCT05387668
- Testing
- BGB-23339
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- BeiGene
COVID-19
Clinical Study of F61 Injection in Healthy Chinese Subjects
Main purpose： To evaluate the safety and tolerability of single-dose ascending intravenous infusion of F61 in healthy subjects. Secondary purpose： To evaluate the pharmacokinetic profile and immunogenicity of F61 administered by…
- Trial name
- NCT05483504
- Testing
- F61 injection
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Wuhan Institute of Biological Products Co., Ltd
HIV Infections
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Trial name
- NCT07818915
- Testing
- VH4367310
- Where
- 2 sites in United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy
Japanese Single and Multiple Ascending Dose (JSMAD), Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) Study of AZD5069
This is a study in Japanese healthy volunteers to determine the safety and tolerability of the compound, AZD5069. It will also assess how the body handles the drug and how it responds to the drug following single and multiple…
- Trial name
- JSMAD (NCT01100047)
- Testing
- AZD5069
- Where
- United Kingdom
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Pneumococcal Vaccine
A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine
The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.
- Trial name
- NCT06337643
- Testing
- MVX01
- Where
- 2 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Matrivax Research and Development Corporation
Hepatic Impairment, Healthy Volunteers
A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
- Trial name
- NCT06985615
- Testing
- Single dose of HDM1002 on Day 1
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
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