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

Phase 1RecruitingNCT06517914

Yuhan Corporation86 enrolled

Overview

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

YH35995 is being developed as a treatment for the neurological symptoms of Gaucher Disease type 3. This study is a first-in-human (FIH), phase 1, randomized, double-blind, placebo-controlled study of YH35995, which consists of two parts. In Part A (SAD), single ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD. In Part B (MAD), multiple ascending dose of YH35995 is administered to healthy male participants to assess its safety, tolerability, PK, and PD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Participants

Interventions

YH35995DRUG

Oral administration of YH35995

PlaceboDRUG

Oral administration of Placebo

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHA Bundang Medical Center

Seongnam, Bundang-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

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

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

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