View clinical trials related to Healthy Volunteers.
Filter by:A Double-Blind, Randomized, Placebo-Controlled, Single Ascending Dose Study to Investigate the Pharmacokinetic Profile of Oral AB680 in Healthy Volunteers.
The primary objective of the study is to assess the safety and tolerability of a single intravenous (IV) dose of dapirolizumab pegol (DZP) in Japanese healthy study participants compared with those of Caucasian healthy study participants. The secondary objectives of the study are to assess the pharmacokinetic(s) (PK) of a single IV dose of DZP in Japanese and Caucasian healthy study participants, to evaluate ethnic sensitivity on the PK of DZP between body weight- and gender-matched Japanese and Caucasian healthy study participants and to evaluate the immunogenicity of a single IV dose of DZP in Japanese and Caucasian healthy study participants.
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.
This study is investigating the safety and tolerability of the new investigational product NNC0363-0845, its concentrations in the blood and its effect on the blood sugar for the treatment of diabetes. The study consists of 3 parts. The first part of the study is conducted in healthy people, while the second part involves people with type 1 diabetes (T1D). Part 3 of this trial involves also people with T1D. The study will test how NNC0363-0845 is tolerated by the body, how it is taken up in the blood, how long it stays there and how much the blood sugar is lowered. Healthy volunteers will either get NNC0363-0845 or placebo - which treatment is decided by chance. Participants with type 1 diabetes will either get NNC0363-0845 or insulin degludec (Tresiba®), also decided by chance. It is the first time that NNC0363-0845 is tested in humans. Participants will get one dose of NNC0363-0845 or placebo or insulin degludec injected into their left thigh. Participation in the study will last for up to 6 weeks. There will be one Informed Consent visit and 6 clinic visits with the study doctor. Healthy volunteers will have blood sampling to measure blood sugar and the concentration of the investigational product in the blood. Participants with type 1 diabetes will have a clamp experiment where the blood sugar is measured and controlled for up to 42 hours. For Part 3, the total duration of the trial for each individual is expected to be approximately 3-9 weeks. Participants cannot be in the study if the study doctor thinks that there are risks for their health. Women can only take part in the study if they are of non-child bearing potential.
The purpose of this study is to assess the way the body absorbs, distributes, breaks down and eliminates radioactive BMS-986278 as well as the safety and tolerability of BMS-986278 in healthy male participants.
The primary purpose of this study is to assess the relative bioavailability of the mitapivat coated granule formulation compared to the tablet formulation following a single oral dose of mitapivat under fasted conditions in healthy adult participants.
The primary objectives of this study are: to evaluate the pharmacokinetic (PK) profiles of BIIB091 modified release (MR) formulations in healthy participants after single dose administration in the fasted state (Part 1); to evaluate the PK profile of the BIIB091 immediate release (IR) tablet formulation in healthy participants after single dose administration (Part 1B); to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a proton pump inhibitor (PPI) compared to healthy participants not taking a PPI, to determine the relative bioavailability of single doses of the selected BIIB091 regimen in healthy participants taking a cytochrome P450 (CYP)3A4 inhibitor compared to healthy participants not taking a CYP3A4 inhibitor (Part 2); to evaluate the PK of the selected BIIB091 regimen in healthy participants after multiple dose administration (Part 3). The secondary objectives of this study are: to determine the relative bioavailability of a single dose of the BIIB091 MR formulations compared to that of the IR drug in capsule (DiC) reference formulation in healthy participants in the fasted state, to assess the safety and tolerability of single doses of BIIB091 when administered as MR formulations in healthy participants in the fasted state (Part 1); to determine the PK of a single dose of the BIIB091 IR tablet formulation in the fed and fasted state in healthy participants, to evaluate the PK profiles of the BIIB091 IR tablet formulation in healthy participants after administration of divided total daily doses over a 24 hour period in the fasted or fed state, to determine the relative bioavailability of a single dose or divided dose of the BIIB091 IR tablet formulation compared to that of the IR DiC reference formulation in healthy participants in the fasted state, to determine the PK of a single or divided dose of the BIIB091 IR tablet formulation administered with an alternative meal composition in healthy participants, to assess the safety and tolerability of a single or divided dose of BIIB091 when administered as the IR tablet formulation and IR DiC reference formulation in healthy participants in fed or fasted state (Part 1B); to confirm the PK profiles of the selected BIIB091 regimen in healthy participants after single dose administration, and to establish a reference exposure for the assessment of drug interaction, to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a PPI, to assess the safety and tolerability of single doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants taking a CYP3A4 inhibitor (Part 2); to assess the safety and tolerability of multiple doses of BIIB091 when administered as the selected BIIB091 regimen in healthy participants (Part 3).
This study will compare the pharmacodynamics, pharmacokinetics and safety of efgartigimod as an intravenous infusion with efgartigimod as a subcutaneous injection in healthy adults.
This is a single center, randomized, double-blind, placebo-controlled, single dose escalation phase 1 study.
This is a single-center, open-label study to be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of [14C]-CC-92480 and to evaluate the safety and tolerability of [14C]-CC-92480 following a single oral dose of [14C]-CC-92480.