Completed

Safety, Tolerability, and Pharmacokinetics of Kappa Receptor Agonist HSK21542 in Healthy Adults

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study Aim

This study aims to evaluate the safety and tolerability of a single injection of Kappa Receptor Agonist HSK21542, compared to a placebo, in healthy adults by observing adverse events and any abnormalities in physical examinations, vital signs, or laboratory parameters.

What is being tested

HSK21542

+ Placebo

Drug
Who is being recruted

Neurologic Manifestations+5

+ Pain

+ Pain, Postoperative

From 18 to 45 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1
Interventional
Study Start: July 2020
See protocol details

Summary

Principal SponsorSichuan Haisco Pharmaceutical Group Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 2, 2020

Actual date on which the first participant was enrolled.

This clinical trial focuses on a drug called HSK21542, which is a kappa receptor agonist. The main goal is to understand its safety and how well it's tolerated by healthy adults after a single dose. This is a Phase 1 study, which is the earliest stage of human testing for a new drug. The study plans to enroll about 50 adults and will last up to 6 months. The results of this study could help pave the way for future research on this drug, potentially leading to new treatments. During this study, participants will receive either HSK21542 or a placebo (a substance that has no therapeutic effect) via a single injection. Neither the participants nor the researchers will know who received the drug or the placebo, making the study 'double-blind'. The study will monitor the participants for any adverse events or abnormalities in physical examinations, vital signs, or laboratory tests. These observations will help evaluate the safety and tolerability of HSK21542.

Official TitleA 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
NCT04110886
Principal SponsorSichuan Haisco Pharmaceutical Group Co., Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and SymptomsChronic Pain

Criteria

5 inclusion criteria required to participate
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 ;
Show More Criteria
11 exclusion criteria prevent from participating
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;
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

CMAX Clinical Research Pty Ltd

Adelaide, AustraliaOpen CMAX Clinical Research Pty Ltd in Google Maps
CompletedOne Study Center