A First-in-Human, Single- and Multiple-Ascending Dose Study of YH35995 in Healthy Adult Male Participants

NCT06517914 | Recruiting Phase 1

• 1 other identifier: YH35995-101
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Participants

Keywords

YH35995; Gaucher Disease

Outcome Measures

Primary Outcomes (1)

• [Part A, B] Treatment-emergent adverse events (TEAEs)

  To assess the safety and tolerability of a single dose and multiple dose administration of YH35995

  Part A: Day1-150, Part B: Day1-232

Secondary Outcomes (22)

• [Part A] Maximum observed plasma concentration (Cmax)

  Day1-150

• [Part A] Time to reach Cmax (Tmax)

  Day1-150

• [Part A] Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)

  Day1-150

• [Part A] AUC from time 0 to infinity (AUCinf)

  Day1-150

• [Part A] Apparent terminal elimination half-life (t1/2)

  Day1-150

Study Arms (2)

YH35995

EXPERIMENTAL

\[Part A\] Participants will be orally administered a single dose of YH35995 in five dose groups, gradually escalating from lower to higher doses. Each cohort includes 10 participants (8 randomly assigned to the YH35995 arm and 2 randomly assigned to the placebo arm). \[Part B\] Participants will receive multiple oral doses of YH35995 once every 4 weeks in three dose groups. Each cohort includes 12 participants (9 randomly assigned to the YH35995 arm and 3 randomly assigned to the placebo arm).

Drug: YH35995

Placebo

PLACEBO COMPARATOR

\[Part A\] Participants will be orally administered a single dose of Placebo in five dose groups, gradually escalating from lower to higher doses. Each cohort includes 10 participants (8 randomly assigned to the YH35995 arm and 2 randomly assigned to the placebo arm). \[Part B\] Participants will receive multiple oral doses of Placebo once every 4 weeks in three dose groups. Each cohort includes 12 participants (9 randomly assigned to the YH35995 arm and 3 randomly assigned to the placebo arm).

Drug: Placebo

Interventions

YH35995 DRUG

Oral administration of YH35995

YH35995

Placebo DRUG

Oral administration of Placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 who are unwilling or unable to comply with the participant guidelines described in this protocol

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13496, South Korea

RECRUITING

MeSH Terms

Conditions

Gaucher Disease

Condition Hierarchy (Ancestors)

Sphingolipidoses; Lysosomal Storage Diseases, Nervous System; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lipidoses; Lipid Metabolism, Inborn Errors; Lysosomal Storage Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism Disorders

Study Officials

• Hyounggyoon Yoo

  CHA Bundang Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeeyeon Kim

CONTACT

+82 2-828-0483; clinicaltrials@yuhan.co.kr

Sungjae Lee

CONTACT

+82 2-828-0366; sjlee@yuhan.co.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is a double-blind study, meaning that YH35995 tablets and placebo tablets will be identical in appearance and will be packaged in the same way. Information about the treatment arm to which participants are assigned must remain blinded for the duration of the study unless information about the causal relationship between the adverse event and the Investigational Product that meets the drug withdrawal criteria becomes essential or, in an emergency, if the information about the Investigational Product becomes critical for treating the participant.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2024
• First Posted: July 24, 2024
• Study Start: July 29, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 1 year and ending 5 years after all trial endpoints were assessed
• Access Criteria: Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to clinicaltrials@yuhan.co.kr

Locations

KR (1)