Actively Recruiting
First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Oral Doses of YH35995 in Healthy Adult Male Participants
Led by Yuhan Corporation · Updated on 2025-11-21
86
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating YH35995, a new drug being developed to treat neurological symptoms of Gaucher Disease type 3. This first-in-human, phase 1 study is randomized, double-blind, and placebo-controlled. It aims to assess the safety, tolerability, how the drug moves and acts in the body after single and multiple doses in healthy adult male participants aged 19 to 45 years. The study has two parts: Part A involves single ascending doses where participants receive a single oral dose of YH35995 or placebo in five increasing dose groups. Part B involves multiple ascending doses where participants take oral doses of YH35995 or placebo once every four weeks in three dose groups. Each part includes randomized groups receiving either the drug or placebo to compare effects. Participants will be monitored for treatment-emergent adverse events over approximately 150 days in Part A and 232 days in Part B. Researchers will also measure detailed pharmacokinetic and pharmacodynamic parameters, including drug concentration in plasma and cerebrospinal fluid, and drug effects over time. This comprehensive monitoring ensures thorough evaluation of safety and drug behavior throughout the study duration.
CONDITIONS
Brief Title
A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male between the ages of 19 and 45 at the time of providing written consent
- Weight of at least 50 kg at screening
- Body mass index (BMI) of at least 18.0 kg/m2 and less than 30 kg/m2
- Fully informed about the study, voluntarily agreeing to participate and comply with study guidelines
You will not qualify if you...
- Participation in a bioequivalence or any other clinical trial within 6 months before the first dose (within 1 month for dietary supplement trials)
- Clinically significant abnormal results not covered by other criteria, as determined by the investigator
- Unwillingness or inability to comply with the study guidelines
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 8 months depending on dosing part
Participants receive either a single ascending dose or multiple ascending doses of YH35995 or placebo to assess safety, tolerability, and pharmacokinetics.
Single dose group: 1 dosing visit; Multiple dose group: dosing once every 4 weeks in up to 3 cycles
Duration - Up to approximately 5 months after last dose
Participants are monitored for treatment-emergent adverse events and other safety outcomes after dosing completion.
Scheduled visits for safety assessments until Day 150 for single dose and Day 232 for multiple dose participants
Trial Site Locations
Total: 1 location
1
CHA Bundang Medical Center
Seongnam, Bundang-gu, South Korea, 13496
Actively Recruiting
Research Team
J
Jeeyeon Kim
S
Sungjae Lee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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