Study design and treatment
ADVERSE EVENT
This study was a randomized, double-blinded, placebo-controlled, dose-ascending, phase 1 trial of SHR7280 in healthy male subjects (NCT04554043).Eligible male subjects received oral SHR7280 tablets or placebo twice daily for 14 consecutive days. Seven dose cohorts (100, 200, 350, 500, 600, 800, and 1000 mg BID) were preplanned. The starting dose, frequency of dosing, and maximum dose were determined based on the PK data and tolerability findings from a phase 1 trial of SHR7280 in healthy premenopausal women, which showed acceptable tolerability of SHR7280 within the dose range of 50 to 400 mg (registered at Dose escalation would be terminated if any of the following criteria were met: occurrence of a serious adverse event (AE) related to SHR7280; occurrence of severe AE of the same organ system related to SHR7280 occurred in ≥ 2 subjects in the same dose group; or ≥ 50% of subjects in the same dose group having moderate or severe AEs related to SHR7280.