NCT04110886

Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a Kappa Receptor Agonist HSK21542 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers. The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.

Conditions

• Postoperative Pain
• Chronic Pain

Interventions

Type	Name	Description
DRUG	HSK21542	Single dose, injection, starting dose of 0.2ug escalating up to 20ug
DRUG	Placebo	Single dose, injection matching placebo

Timeline

• Start date: 2020-07-02
• Primary completion: 2020-12-08
• Completion: 2021-01-05
• First posted: 2019-10-01
• Last updated: 2021-02-09

Locations

1 site across 1 country: Australia