Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

NCT ID: NCT04110886

Last Updated: 2021-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-02
• Study Completion Date: 2021-01-05

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HSK21542 single ascending doses

Group Type: EXPERIMENTAL

HSK21542

Intervention Type: DRUG

Single dose, injection, starting dose of 0.2ug escalating up to 20ug

Placebo single dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single dose, injection matching placebo

Interventions

HSK21542

Single dose, injection, starting dose of 0.2ug escalating up to 20ug

Intervention Type: DRUG

Placebo

Single dose, injection matching placebo

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Haisco Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Wabnitz, PhD

Role: PRINCIPAL_INVESTIGATOR

CMAX Clinical Research Pty Ltd

Locations

CMAX Clinical Research Pty Ltd

Adelaide, , Australia

Countries

Australia

Other Identifiers

HSK21542-101

Identifier Type: -

Identifier Source: org_study_id