NCT06517914Active, not recruitingPhase 1
A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants
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
Source: ClinicalTrials.gov · Last updated 28 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 94 (actual)
- First submitted
- 14 Jul 2024
- Start date
- 29 Jul 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- Yuhan Corporation
- Diseases
- Gaucher disease
- NCT number
- NCT06517914
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 94
- From 29 Jul 2024 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to 45 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHA Bundang Medical Center Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.