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Active Not Recruiting NCT06517914

A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants

Conditions: Healthy Participants

Sex: Male
Ages: 19 Years – 45 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 94
Sponsor: Yuhan Corporation

Location: CHA Bundang Medical Center Seongnam Bundang-gu

Summary

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

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06517914). StuddyBuddy aggregates publicly available trial information.