Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06542237
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-03
Brief Title:
Open Label Repeat Dose Study Evaluating YCT-529 in Healthy Males
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Open Label Dose Escalation Study to Evaluate Safety Tolerability Pharmacokinetics and Pharmacodynamics of Repeated Daily Oral Dosing of YCT-529 for 28 Days in Healthy Men
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label 2 part-study 28-day 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
Detailed Description:
This is a Phase 1b2a multicenter open label 28-Day repeat-dose escalation study of YCT-529 in healthy men to evaluate the safety tolerability PK and PD and to assess sexual function and mood Cohorts will be dosed in the fasted or fed state In the Phase
1b part 4 dosing cohorts and one optional 5th cohort with 4 participants each will be evaluated All participants will receive YCT-529 In the Phase 2a part up to 3 cohorts will receive doses within the range of doses that was well tolerated and had biological activity in the Phase 1b portion Each Phase 2a cohort will have up to 10 participants
All participants will receive YCT-529
The study population in both parts of the study will include healthy men who have decided to have a vasectomy and are waiting for the procedure and men who in the opinion of the investigator have made a firm decision not to father children in the future
1b part 4 dosing cohorts and one optional 5th cohort with 4 participants each will be evaluated All participants will receive YCT-529 In the Phase 2a part up to 3 cohorts will receive doses within the range of doses that was well tolerated and had biological activity in the Phase 1b portion Each Phase 2a cohort will have up to 10 participants
All participants will receive YCT-529
The study population in both parts of the study will include healthy men who have decided to have a vasectomy and are waiting for the procedure and men who in the opinion of the investigator have made a firm decision not to father children in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None