First in Man Study to Evaluate Single Ascending Doses of Oral YCT-529 (QSC300528)
Research type
Research Study
Full title
Double-blind, placebo controlled, first in human study to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of YCT-529
IRAS ID
1007466
Contact name
Akash Bakshi
Contact email
Sponsor organisation
YourChoice Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, YCT-529, designed to reduce production of sperm count and sperm motility as a means for male contraception.
This first-in-human healthy volunteer study will try to identify the safety and tolerability of YCT-529 and the pharmacokinetics (PK - what the body does to the drug) of YCT-529 when given in single ascending oral doses. In addition, the study aims to assess how the drug effects the body (ie sperm production). A food effect assessment may also be employed.
This study will take place at one non-NHS site (Quotient Sciences Limited), with semen sample collection at one NHS-site in a private capacity. This study will enroll approximately 54 male volunteers aged 18-55.
This study consists of two periods. In Period 1, 5 cohorts (9 volunteers per cohort) will receive an oral dose of YCT-529 or placebo [7:2] following an overnight fast. The planned start dose is 10 mg. Two volunteers per cohort [1:1 YCT-529: placebo] will be dosed ahead of the full cohort (sentinel dosing) to assess if the dose level is safe. The dose given to volunteers in later cohorts may be higher than previously given pending review of PK and safety data. A further optional cohort may be utilised if required.
Period 2 will assess the impact food has on YCT-529, whereby 1 cohort from Period 1 will receive YCT-529 in the fed state [7:2 YCT-529: placebo].
Volunteers will be discharged on Day 3 and will return for follow-up visits on Day 5, 7, 9, 15 and 28 (±1 day) for both periods. Following final dose volunteers will return on Day 60 (±7 days) and if required, Day 120 (±7 days) for semen assessments. Blood, urine and semen will be taken throughout the study for analysis of YCT-529, pharmacodynamic effects (effect on semen; measure of immune response) and for safety.
The maximum time volunteers are expected to be involved in this study is approximately 25 weeks from screening to the final follow-up visit (Day 120).
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0204
Date of REC Opinion
8 Aug 2023
REC opinion
Further Information Favourable Opinion