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Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

CompletedPhase 1NCT04110886
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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
Interventions
Sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd
Organization
Haisco Pharmaceutical Group Co., Ltd.
Start date
2020-07-02
Primary completion
2020-12-08
Sex
All
Age range
from 18 Years to 45 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
Australia
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04110886