What is YH35995 studying for neurological symptoms of Gaucher Disease type 3?

YH35995 is being studied to understand its safety, tolerability, and how it behaves in the body when given as single or multiple oral doses. This trial helps researchers learn more about the drug's effects in healthy adult males. The study is sponsored by Yuhan Corporation and aims to advance treatment options for neurological symptoms in Gaucher Disease.

Who may be eligible for this healthy adult male clinical trial?

Men aged 19 to 45 years who weigh at least 50 kg with a BMI between 18.0 and 30 kg/m2 may be eligible. Participants must be healthy and able to follow study rules. People who have joined other clinical trials in the last 6 months are not eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this healthy adult male clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and might not be covered by the study.

Actively Recruiting

Phase 1

Age: 19Years - 45Years

MALE

Healthy Volunteers

ID06517914

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

Participants Needed

Research Sites

N/A

Total Duration

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

Age: 19Years - 45Years

MALE

Healthy Volunteers

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

Research Team

Jeeyeon Kim

Sungjae Lee

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