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YourChoice Therapeutics, Inc., a pioneer of hormone-free family planning products, began dosing male volunteers in a Phase I study of YCT-529, a drug candidate designed to offer the first hormone-free birth control pill for men.
Quotient Sciences is supporting the development of YCT-529 with YourChoice Therapeutics. YCT-529 is a drug candidate designed to offer the first hormone-free birth control pill for men.
YCT-529 is a retinoic acid receptor-alpha (RAR-alpha) inhibitor that prevents sperm production by blocking access to vitamin A. This was first discovered in the 1930s when researchers found that depriving mice, rats, and monkeys of vitamin A caused infertility. Researchers validated the discovery in men and advanced their understanding in nearly 100 published papers in the decades that followed. Initial preclinical studies, funded in part by the National Institutes of Health, showed YCT-529 was 99% effective and 100% reversible with no side effects.
Quotient Sciences is conducting the Phase I study from its Nottingham, UK clinic. The Phase I study will investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of YCT-529 in 16 participants (2 cohorts of 8 subjects). Cohorts 1 and 2 will be dosed in the fasted state in Periods 1 and 2. Each cohort will receive two doses of study drug separated by a washout period. One cohort will then return for a third dose of study drug under fed conditions in Period 3 to study the effect of food on YCT-529.