Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT04110886

Collaborator

(none)

120

Enrollment

Location

Arms

6.1

Actual Duration (Months)

19.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Chronic Pain	Drug: HSK21542 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 2, 2020

Actual Primary Completion Date :

Dec 8, 2020

Actual Study Completion Date :

Jan 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HSK21542 single ascending doses	Drug: HSK21542 Single dose, injection, starting dose of 0.2ug escalating up to 20ug
Placebo Comparator: Placebo single dose	Drug: Placebo Single dose, injection matching placebo

Arm

Intervention/Treatment

Experimental: HSK21542 single ascending doses

Drug: HSK21542

Single dose, injection, starting dose of 0.2ug escalating up to 20ug

Placebo Comparator: Placebo single dose

Drug: Placebo

Single dose, injection matching placebo

Outcome Measures

Primary Outcome Measures

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

Cmax [From the start of administration to 24 hours after administration]
Maximum (peak) plasma drug concentration
Tmax [From the start of administration to 24 hours after administration]
Time to reach maximum (peak) plasma concentration following drug administration
t1/2 [From the start of administration to 24 hours after administration]
Elimination half-life
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.
AUC0-inf [From the start of administration to 24 hours after administration]
Area under the plasma concentration-time curve from time zero to infinity
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMAX Clinical Research Pty Ltd	Adelaide		Australia

Sponsors and Collaborators

Sichuan Haisco Pharmaceutical Group Co., Ltd

Investigators

Principal Investigator: Paul Wabnitz, PhD, CMAX Clinical Research Pty Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sichuan Haisco Pharmaceutical Group Co., Ltd

ClinicalTrials.gov Identifier:

NCT04110886

Other Study ID Numbers:

HSK21542-101

First Posted:

Oct 1, 2019

Last Update Posted:

Feb 9, 2021

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sichuan Haisco Pharmaceutical Group Co., Ltd

Pain

Postoperative Pain

Additional relevant MeSH terms:

Chronic Pain

Pain, Postoperative

Study Results

No Results Posted as of Feb 9, 2021