Testing YH35995 in healthy adult males
A First-in-Human, Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following Oral Administration of YH35995 in Healthy Adult Male Participants
This study is testing a new treatment called YH35995 in healthy adult men to see if it’s safe and how it works for people with neurological symptoms from Gaucher Disease type 3.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Ages | 19 Years to 45 Years |
| Sex | Male |
| Sponsor | Yuhan Corporation Industry-sponsored |
| Locations | 1 site (Seongnam, Bundang-gu) |
| Trial ID | NCT06517914 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human, phase 1 clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YH35995, a potential treatment for neurological symptoms associated with Gaucher Disease type 3. The study consists of two parts: a single ascending dose (SAD) administered to healthy male participants, followed by a multiple ascending dose (MAD) phase. Participants will receive either YH35995 or a placebo in a randomized, double-blind manner to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult males aged 19 to 45 who meet specific weight and BMI criteria.
Not a fit: Patients who are not male or fall outside the specified age range or health criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients suffering from Gaucher Disease type 3.
How similar studies have performed: While this is a first-in-human study, similar approaches in early-phase trials have shown promise in evaluating new treatments for rare diseases.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seongnam, Bundang-gu
- CHA Bundang Medical Center — Seongnam, Bundang-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyounggyoon Yoo — CHA Bundang Medical Center
- Study coordinator: Jeeyeon Kim
- Email: clinicaltrials@yuhan.co.kr
- Phone: +82 2-828-0483
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.