NCT05023525

A Study of Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Pharmacokinetics of Single Ascending Dosed of HSK31858 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase I, single-dose escalation clinical trial for HSK31858 conducted in healthy volunteers. The safety, tolerability, and pharmacokinetics of HSK31858 tablet in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	HSK31858, tablet	Starting dose in single ascending dose: 5 mg
DRUG	Placebo, tablet	Matching placebo

Timeline

• Start date: 2021-10-28
• Primary completion: 2022-04-19
• Completion: 2022-08-16
• First posted: 2021-08-26
• Last updated: 2022-09-06

Locations

1 site across 1 country: Australia