Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

Study Overview
=================
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.

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

Conditions
-----------------
Postoperative Pain, Chronic Pain

Intervention / Treatment
-----------------
* Drug: HSK21542
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK21542 single ascending doses<br> | Drug: HSK21542<br>* Single dose, injection, starting dose of 0.2ug escalating up to 20ug<br>|
| Placebo Comparator: Placebo single dose<br> | Drug: Placebo<br>* Single dose, injection matching placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events | To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events | Between screening and 7-9 days after dosing | 
| Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters | 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 | Between screening and 7-9 days after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum (peak) plasma drug concentration | From the start of administration to 24 hours after administration | 
| Tmax | Time to reach maximum (peak) plasma concentration following drug administration | From the start of administration to 24 hours after administration | 
| t1/2 | Elimination half-life | From the start of administration to 24 hours after administration | 
| AUC0-t | Area under the plasma concentration-time curve from time zero to time t. | From the start of administration to 24 hours after administration | 
| AUC0-inf | Area under the plasma concentration-time curve from time zero to infinity | From the start of administration to 24 hours after administration | 
| CL | Apparent total body clearance of the drug from plasma | From the start of administration to 24 hours after administration | 
| Vd | Apparent volume of distribution | From the start of administration to 24 hours after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Postoperative Pain