NCT06094283

First in Human Study Evaluating Single Ascending Oral Doses of YCT-529 in Healthy Males

Double-blind, Placebo Controlled, First in Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Oral Doses of YCT-529

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: YourChoice Therapeutics, Inc. · Industry
• Sex: Male
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A single ascending oral dose(s) study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YCT-529 in healthy male subjects.

Detailed description

This is a Phase 1a, double-blind, placebo controlled, first in human study to evaluate the safety, tolerability, PK, and PD of YCT-529 in 2 cohorts of 8 subjects. Cohorts 1 and 2 will be dosed in the fasted state in Periods 1 and 2. Each cohort will receive two doses of study drug separated by a washout period. One cohort will then return for a third dose of study drug under fed conditions in Period 3 to study the effect of food on YCT-529.

Conditions

• Male Contraception

Interventions

Type	Name	Description
DRUG	YCT-529	Single oral dose (planned doses of 10, 30, 90 and 200 mg; dose levels will not exceed 250 mg
DRUG	YCT-529 Placebo	YCT-529 Placebo

Timeline

• Start date: 2023-12-20
• Primary completion: 2024-06-18
• Completion: 2024-06-18
• First posted: 2023-10-23
• Last updated: 2024-10-02

Locations

1 site across 1 country: United Kingdom