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.
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.
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, AST, GGT and ALP 2-fold above the upper limit of normal. Volunteers with known Gilbert's syndrome will be excluded if total bilirubin is ≥1.5 x ULN.
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) .
Sequential
YCT-529
DrugIn 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.
The incidence and nature of any adverse events, dose-limiting adverse events and serious adverse adverse events.
Assessment of the number and type of adverse events, dose-limiting adverse events and serious adverse events following dosing.
Vital signs assessment (heart rate)
Changes from pre-dose values (beats per minute)
Vital signs assessment (blood pressure)
Changes from pre-dose values (mm hg)
Vital signs assessment (oral temperature)
Changes from pre-dose values (temperature in celsius degrees)
Plasma PK Parameter of YCT-529 (Area under the curve to Infinity [AUCinf])
Plasma PK Parameter as measured by area under the curve from time 0 extrapolated to infinity \[AUCinf\]
Plasma PK Parameter of YCT-529 (Area under the curve to the last measured concentration [AUC0-t])
Plasma PK Parameter as measured by area under the curve from time 0 to the last measured concentration \[AUC0-t\]
Plasma PK Parameter of YCT-529 (Area under the curve to 24 hours [AUC0-24])
Plasma PK Parameter as measured by area under the curve from time 0 to 24 hours \[AUC0-24\]
Plasma PK Parameter of YCT-529 (Time to maximum concentration [Tmax])
Plasma PK Parameter as measured by time to maximum concentration \[Tmax\]
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