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NCT Number: NCT06517914

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

19 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

CHA Bundang Medical Center

Seongnam, Bundang-gu, 13496, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH35995

Drug

Oral administration of YH35995

Placebo

Drug

Oral administration of Placebo

Primary outcomes

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

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

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

Secondary outcomes

  1. [Part A] Maximum observed plasma concentration (Cmax)

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

  2. [Part A] Time to reach Cmax (Tmax)

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

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

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

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

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

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

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

  6. [Part A] Total plasma clearance (CL/F)

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

  7. [Part A] Apparent volume of distribution (Vz/F)

    Time frame: Day1-150

    To characterize the pharmacokinetics (PK) of YH35995

  8. [Part B] Cmax during the first dosing interval

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  9. [Part B] Tmax during the first dosing interval

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  10. [Part B] AUC during the first dosing interval (AUCsingle)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  11. [Part B] AUC during the dosing interval at steady state (AUCtau,ss)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  12. [Part B] Cmax at steady state (Cmax,ss)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  13. [Part B] Tmax at steady state (Tmax,ss)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  14. [Part B] Accumulation ratio using AUC (Rac(AUC))

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  15. [Part B] Accumulation ratio using Cmax (Rac(Cmax))

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  16. [Part B] Plasma concentration at the last observed time point during the dosing interval at steady state (Ctrough)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  17. [Part B] Average plasma concentration (Cavg)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  18. [Part B] Clearance at steady state (CLss/F)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  19. [Part B] Volume of distribution at steady state (Vss)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  20. [Part B] Effective half-life (t1/2,Rac)

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  21. [Part B] Cerebrospinal fluid to plasma concentration ratio(C/P ratio) of YH35995

    Time frame: Day1-232

    To assess the pharmacokinetics (PK) of YH35995 after multiple dose administration

  22. [Part B] Properly derived PD parameters for YH35995, including the area under the effect curve (AUEC) and maximum effect (Emax)

    Time frame: Day1-232

    To assess the pharmacodynamics (PD) of YH35995 after multiple dose administration

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2024
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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