About this trial
This is a randomized, double-blind, first-in-human study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral doses of YH35995
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male between the ages of 19 and 45 at the time of providing written consent
Participants who weigh at least 50 kg at screening and have a body mass index (BMI) of at least 18.0 kg/m2 and less than 30 kg/m2
Participants who have been fully informed about and fully understand this study, have voluntarily decided to participate, and have agreed in writing to comply with the guidelines of the study during the duration of the study
Disqualifiers
Participation in a bioequivalence trial or any other clinical trials within 6 months prior to the first scheduled dose of the IP (within 1 month of the first scheduled dose for participants who have taken part in a dietary supplement clinical trial)
Individuals with clinically significant abnormal results that do not match any other inclusion/exclusion criteria, as determined by the principal investigator and the delegated persons(investigator)
Individuals who are unwilling or unable to comply with the participant guidelines described in this protocol
Trial design
Parallel
Treatments tested in this trial
YH35995
DrugOral administration of YH35995
Placebo
DrugOral administration of Placebo
Treatment groups
Trial outcomes
Primary outcomes
[Part A, B] Treatment-emergent adverse events (TEAEs)
To assess the safety and tolerability of a single dose and multiple dose administration of YH35995
Secondary outcomes
[Part A] Maximum observed plasma concentration (Cmax)
To characterize the pharmacokinetics (PK) of YH35995
[Part A] Time to reach Cmax (Tmax)
To characterize the pharmacokinetics (PK) of YH35995
[Part A] Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the pharmacokinetics (PK) of YH35995
[Part A] AUC from time 0 to infinity (AUCinf)
To characterize the pharmacokinetics (PK) of YH35995
Sponsors and contacts
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