NCT05663593

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

A 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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2022-02-23
• Primary completion: 2022-08-15
• Completion: 2022-11-30
• First posted: 2022-12-23
• Last updated: 2022-12-23

Locations

1 site across 1 country: China