Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
Lead Sponsor:
Sichuan Haisco Pharmaceutical Group Co., Ltd
Conditions:
Postoperative Pain
Chronic Pain
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 Hea...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04110886
Start Date
July 2 2020
End Date
January 5 2021
Last Update
February 9 2021
Active Locations (1)
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1
CMAX Clinical Research Pty Ltd
Adelaide, Australia