Actively Recruiting
Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
Led by YourChoice Therapeutics, Inc. · Updated on 2026-02-13
88
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant in good health as confirmed by physical examination, medical history, and clinical laboratory tests.
- Participant must provide written informed consent.
- Participant must be willing and able to communicate and participate in the whole study.
- Participant is 28 to 70 years of age (inclusive) at the time of consent.
- Participant has decided to have a vasectomy and is waiting for the procedure or has made a firm decision not to father children in the future.
- Participant has a body mass index (BMI) 18.0 to 35.0 kg/m2.
- Participant has no history of hormonal therapy or 5-alpha reductase inhibitors use in the 90 days prior to the first screening visit.
- Participant with partner(s) of childbearing potential agrees to use a highly effective contraception method or total abstinence during the study until 28 days after the last dose.
- Condom use is required during the study with partners of childbearing and non-childbearing potential until Day 56 (Part 1) or Day 118 (Parts 2 and 3).
- Participant will refrain from donating blood or plasma during the study.
- Participant will not use cannabis or recreational drugs for at least 30 days before screening and during the study.
- Participant is able to adhere to study requirements, restrictions, schedule of assessments, and semen sample collection and diary maintenance.
- Participant provides at least 2 (Part 1) or 3 (Parts 2 and 3) semen samples during screening with sperm parameters within the normal range as specified.
You will not qualify if you...
- Participation in another clinical study with an investigational drug within 30 days or less than 5 half-lives before first dosing.
- Clinically significant abnormal physical or laboratory findings at screening.
- Abnormal serum chemistry indicating liver or kidney dysfunction, except certain bilirubin and enzyme levels.
- Evidence of renal impairment with estimated eGFR below 80 mL/min/1.73 m2.
- Use of androgens or selective androgen receptor modulators within 90 days before screening.
- Body weight below 55 kg.
- High blood pressure above specified limits based on age.
- Clinically significant abnormal ECG or QTc interval over 450 msec.
- History of androgen deficiency or multiple endocrine deficiencies.
- Significant cardiovascular, renal, hepatic, or prostatic disease.
- Current or relevant history of psychiatric disorders or significant suicidal risk.
- Serious drug allergy or hypersensitivity.
- Clinically significant allergies requiring treatment (seasonal allergies allowed).
- Positive tests for hepatitis B, hepatitis C, or HIV at screening.
- Known or suspected alcoholism or drug abuse in the last 2 years affecting hormone metabolism or compliance.
- Unsuitable veins for multiple blood draws.
- Regular alcohol use over 21 units per week.
- Current smokers with at least 5 cigarettes or equivalent nicotine per week in last 3 months.
- Positive drug or marijuana/cannabis test at screening or admission.
- Use of prescribed or over-the-counter drugs, vitamins, herbal remedies, or supplements except specified exceptions in the 14 days before study drug administration.
- Male volunteers with pregnant or lactating partners.
- Site staff members or their family involved in the study.
- Any other medical condition that could affect well-being, study conduct, or data interpretation as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
New Zealand Clinical Research (NZCR)
Grafton, Auckland, New Zealand, 1010
Actively Recruiting
Research Team
N
Nadja Mannowetz, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
1
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