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Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

Primary Purpose

Postoperative Pain, Chronic Pain

Status

Completed

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

HSK21542

Placebo

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Pain, Postoperative Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

CMAX Clinical Research Pty Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HSK21542 single ascending doses

Placebo single dose

Arm Description

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Cmax

Maximum (peak) plasma drug concentration

Tmax

Time to reach maximum (peak) plasma concentration following drug administration

t1/2

Elimination half-life

AUC0-t

Area under the plasma concentration-time curve from time zero to time t.

AUC0-inf

Area under the plasma concentration-time curve from time zero to infinity

Apparent total body clearance of the drug from plasma

Apparent volume of distribution

Full Information

NCT ID

NCT04110886

First Posted

August 27, 2019

Last Updated

February 5, 2021

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04110886

Brief Title

Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

July 2, 2020 (Actual)

Primary Completion Date

December 8, 2020 (Actual)

Study Completion Date

January 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Chronic Pain

Keywords

Pain, Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HSK21542 single ascending doses

Arm Type

Experimental

Arm Title

Placebo single dose

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

HSK21542

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single dose, injection matching placebo

Primary Outcome Measure Information:

Title

Number of subjects with adverse events

Description

To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events

Time Frame

Between screening and 7-9 days after dosing

Title

Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters

Description

Time Frame

Between screening and 7-9 days after dosing

Secondary Outcome Measure Information:

Title

Cmax

Description

Maximum (peak) plasma drug concentration

Time Frame