Status:
RECRUITING
A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
Lead Sponsor:
Yuhan Corporation
Conditions:
Healthy Participants
Eligibility:
MALE
19-45 years
Phase:
PHASE1
Brief 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
Detailed Description
YH35995 is being developed as a treatment for the neurological symptoms of Gaucher Disease type 3. This study is a first-in-human (FIH), phase 1, randomized, double-blind, placebo-controlled study of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06517914
Start Date
July 29 2024
End Date
June 1 2027
Last Update
November 21 2025
Active Locations (1)
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1
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea, 13496