Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
Open Label Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Repeated Daily Oral Dosing of YCT-529 for 28 Days, 90 Days or 180 Days in Healthy Men
YourChoice Therapeutics, Inc.
88 participants
Sep 11, 2024
INTERVENTIONAL
Conditions
Summary
This is a Phase 1b/2a open-label, dose escalation 3 part-study, 28-day, 90-day or 180 day repeat dose study of YCT-529 in healthy males who have decided to have a vasectomy and are waiting for the procedure and for men who have decided not to father children in the future. The study is aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and to assess sexual function and mood.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
In Part 1, 4 dosing cohorts and one optional 5th cohort with 4 participants each will be evaluated. In Part 2, up to 5 dosing cohorts and 2 optional cohorts with 4 participants each will be evaluated. Dose levels will be selected based on doses that were deemed safe and well tolerated upon 28-day administration in Part 1 and any previous Part 2 cohorts. In Part 3, 3 dosing cohorts and one optional 4th cohort with 10 participants each will receive doses within the range of doses that were deemed safe and well tolerated in Part 2.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06542237