Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
- Registration Number
- NCT04110886
- Lead Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo single dose Placebo - HSK21542 single ascending doses HSK21542 -
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events Between screening and 7-9 days after dosing To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events
Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters Between screening and 7-9 days after dosing To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
- Secondary Outcome Measures
Name Time Method t1/2 From the start of administration to 24 hours after administration Elimination half-life
Tmax From the start of administration to 24 hours after administration Time to reach maximum (peak) plasma concentration following drug administration
AUC0-t From the start of administration to 24 hours after administration Area under the plasma concentration-time curve from time zero to time t.
CL From the start of administration to 24 hours after administration Apparent total body clearance of the drug from plasma
Vd From the start of administration to 24 hours after administration Apparent volume of distribution
Cmax From the start of administration to 24 hours after administration Maximum (peak) plasma drug concentration
AUC0-inf From the start of administration to 24 hours after administration Area under the plasma concentration-time curve from time zero to infinity
Trial Locations
- Locations (1)
CMAX Clinical Research Pty Ltd
🇦🇺Adelaide, Australia