View clinical trials related to Healthy Adult Subjects.
Filter by:This study will assess the potential for clinical drug-drug interactions between omaveloxolone and a number of substrates and inhibitors of metabolic enzymes and drug transporters.
The purpose of the study is to assess the relative bioavailability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) compared to 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants. This study will also evaluate the safety and tolerability of single doses of 100 mg roxadustat pediatric azo dye-free tablet and 100 mg roxadustat pediatric azo dye-free mini-tablet solid and suspension (new formulations) and a single dose of 100 mg roxadustat azo dye-containing tablet (reference formulation) under fasting conditions in healthy male and female adult participants.
TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).
To evaluate the pharmacokinetics of different dose levels and dose formulations of pegilodecakin in healthy adult participants.
To evaluate the pharmacokinetics of single and multiple doses of pegilodecakin in healthy participants.
This is the first clinical trial to evaluate ascending multiple oral doses in healthy adult and healthy elderly subjects to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIIB118
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of single ascending IV doses of GMI-1271 in healthy adult subjects.
objective: To assess the safety, tolerability and pharmacokinetics of metadoxine, administered as repeated oral doses of MG01CI tablets (2 X 700 mg metadoxine per administration), to healthy adult subjects. This is a single center, open-label, repeated-dose study in healthy male and female volunteers. Subjects will undergo screening within 21 days prior to the first dosing to assess their eligibility to participate in the study. All subjects will receive 1400 mg metadoxine as two MG01CI oral extended-release tablets, administered once daily for five consecutive days. Blood samples for metadoxine (which consists of two components: pyrrolidone-5-carboxylate and pyridoxine that can be identified in plasma concentration assays) will be drawn at designated time points, as described in the pharmacokinetic (PK) evaluation section. The subjects will remain confined to the unit for 6 days after first dosing. A study termination visit will take place 10-12 days after the last dosing day. The subjects will be monitored for safety, and AEs (Adverse events) will be recorded throughout the study.
The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952 in healthy subjects.
The primary objective of this study is to evaluate the safety and tolerability of ONO-4053 across ascending single and multiple doses in healthy adult male and female subjects. The secondary objective of the study is to characterize the pharmacokinetic profile of ONO-4053 in healthy adult male and female subjects.