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New treatment option for Male Contraception
Official title Open Label, Dose Escalation, Repeat Dose Study Evaluating YCT-529 in Healthy Males
ClinicalTrials.gov ID: NCT06542237
What this study is testing
What is YCT-529?
YCT-529 is an investigational medicine, being studied as a potential treatment for male contraception.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 28 to 70, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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 participant, in the opinion of the investigator, has made a firm...
You likely can't join if
- Men participating in another clinical study involving an investigational drug within the last 30 days prior to the first dosing or less than 5...
- Clinically significant abnormal physical and/or laboratory findings at Screening
- Abnormal serum chemistry values at screening or admission, that indicate liver or kidney dysfunction or that may be considered clinically significant...
- Evidence of renal impairment at screening, as indicated by an estimated eGFR of \<80 mL/min/1.73 m2 using the 2021 CKD-EPI Creatinine Equation...
- Use of androgens and selective androgen receptor modulators (SARMs) within 90 days before first screening visit.
- Volunteers with a body weight \< 55 kg.
See the full eligibility criteria
Who can join
- 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 participant, in the opinion of the investigator, 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 method of contraception that is highly effective with any partner (i.e., total abstinence or at a minimum, barrier method plus additional method of...
- Participant will refrain from donating blood or plasma during the study.
- Participant will not use cannabis or any other recreational drugs for at least 30 days before the Screening visit and during the study. The marijuana/cannabis test can be positive at Screening but needs to be negative...
- Part 1: In the opinion of the investigator, participant is able to adhere to the study requirements, restrictions, schedule of assessments, and requirements related to sperm sample collection and maintenance of the...
- Part 1: Participant providing at least 2 semen samples during the screening period with sperm parameters within at least the 5th percentile of the WHO range of normality (WHO, 2010 and WHO, 2021):
- 15 million sperm cells/mL
- 39 million sperm cells/total ejaculate
- 40% total motility
- 30% progressive motility Parts 2 and 3: Participant providing 3 semen samples during the screening period with ≥ 15 million sperm cells/mL (at least the 5th percentile of the WHO range of normality [WHO, 2021]).
What rules you out
- Men participating in another clinical study involving an investigational drug within the last 30 days prior to the first dosing or less than 5 elimination half-lives prior to first dosing, whichever is longer.
- Clinically significant abnormal physical and/or laboratory findings at Screening
- Abnormal serum chemistry values at screening or admission, that indicate liver or kidney dysfunction or that may be considered clinically significant as determined by the PI, except for bilirubin \>24 μmol/L and ALT...
- Evidence of renal impairment at screening, as indicated by an estimated eGFR of \<80 mL/min/1.73 m2 using the 2021 CKD-EPI Creatinine Equation (https://www.kidney.org/professionals/kdoqi/gfr\_calculator) .
- Use of androgens and selective androgen receptor modulators (SARMs) within 90 days before first screening visit.
- Volunteers with a body weight \< 55 kg.
- Systolic blood pressure (BP) \>140 mmHg (\ 160 mmHg (≥45 years) and diastolic BP \>90 mmHg at screening and admission.
- Clinically significant abnormal electrocardiogram (ECG) or a duration of corrected QT interval using Bazett's and Fridericia's QT correction methods in ECG (QTc) interval of \>450 msec at screening or predose.
- Known history of androgen deficiency due to hypothalamic-pituitary or testicular disease or multiple endocrine deficiencies.
- Known history of significant cardiovascular, renal, hepatic (cholecystectomy is not permitted), or prostatic disease. Gilbert's syndrome is allowed (volunteer with known Gilbert's syndrome will be excluded if total...
- Current or clinically relevant history of any psychiatric disorder or clinical assessment of significant suicidal risk or risk of self-injury as per the Investigator's judgement.
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Seasonal allergies (e.g., hay fever) are allowed unless considered clinically significant by the investigator.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) 1 and 2 antibody results at screening visit.
- Known or suspected alcoholism or drug abuse within the last 2 years that may affect metabolism/transformation of steroid hormones or study treatment compliance.
- Volunteers who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening.
- Regular alcohol consumption in males \>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type.
- Current smokers who have consumed at least 5 cigarettes or equivalent amount of nicotine per week within the last 3 months prior to Screening.
- Confirmed positive drugs of abuse test result at Screening and admission and/or positive marijuana/cannabis test at admission (Day -1).
- Participants and volunteers who are taking, or have taken, any prescribed or over-the-counter drug or vitamins/herbal remedies/supplements (other than up to 4 g of paracetamol or up to 3.2 g of ibuprofen per day during...
- Male volunteer with pregnant or lactating partner(s).
- Any site staff member with delegated study responsibilities or a family member of a site staff member with delegated study responsibilities.
- Any other medical condition that, in the opinion of the investigator, could alter the volunteer's well-being, the study conduct, or the interpretability of the results. \-
The study team makes the final eligibility decision.
Where it's taking place
- Grafton, Auckland, New Zealand
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 28 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Grafton, Auckland, New Zealand. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.