Safety, Tolerability,PK/PD, Food Effect of Single and Multiple Ascending Doses of HSK31858 in Healthy Volunteers

Phase 1 Completed 74 enrolled Haisco Pharmaceutical Group Co., Ltd.

RandomizedParallel-groupDouble-blindOther

Summary

This is a phase I, randomised, double-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of HSK31858 in healthy volunteers

Timeline

Start: 2022-02-23
Primary completion: 2022-08-15
Completion: 2022-11-30

Publications

Wang Y, Yu C, Hu M, Wang L, Chen M, Liu H, Wu N, Hou J. Safety, tolerability, pharmacokinetics and pharmacodynamics of HSK31858, a novel oral dipeptidyl peptidase-1 inhibitor, in healthy volunteers: An integrated phase 1, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose study. Br J Clin Pharmacol. 2025 Aug;91(8):2262-2272. doi: 10.1002/bcp.70027. Epub 2025 Apr 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	HSK31858	Unknown	5 mg	Oral
Subject	HSK31858	Unknown	10 mg	Oral
Subject	HSK31858	Unknown	15 mg	Oral
Subject	HSK31858	Unknown	20 mg	Oral
Subject	HSK31858	Unknown	40 mg	Oral
Subject	HSK31858	Unknown	60 mg	Oral
Subject	HSK31858	Unknown	80 mg	Oral

Indications

No indication recorded.