Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-01-05
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd; Sichuan Haisco Pharmaceutical Group Co., Ltd.

Criteria

Inclusion Criteria:

• Healthy male and female subjects, age 18-45 years;

• BMI between 18.0-27.0 kg/m2

• Determined by investigator to be in general good health according to medical history, comprehensive physical examination;

• Understanding of the nature, significance, potential benefits and risks of the trial, understanding of the procedures and be able to provide written informed consent voluntarily ;

• Good communication with investigators, compliance with the study requirements and willingness to stay in phase I clinical trial ward as required.

Exclusion Criteria:

• Anyone who has suffered or is currently suffering from any serious diseases, that may interfere with the results of the trial;

• Determined by investigator to be abnormal with clinical significance in Physical examination, vital signs monitoring, electrocardiogram, chest radiograph, laboratory examination;

• HBsAg positive, HCV antibody positive, Treponema pallidum antibody positive, or HIV antibody positive;

• QTcF > 450ms;

• Allergic constitution;

• Intolerance of venipuncture and/or history of haemorrhage or needle fainting;

• Drug or alcohol abuse;

• Have used any prescription, over-the-counter, Chinese herbal medicine or health products within 14 days;

• Blood donation or massive bleeding within 3 months (greater than 450 mL);

• Participants in any drug clinical trial within 3 months.

• Birth planning in the next six months.