Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Postoperative Pain
• Intervention / Treatment: Drug: HSK21542; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • CMAX Clinical Research Pty Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

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

Collaborators and Investigators

• Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd
• Investigators: Principal Investigator: Paul Wabnitz, PhD, CMAX Clinical Research Pty Ltd

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 2, 2020
• Primary Completion (ACTUAL): December 8, 2020
• Study Completion (ACTUAL): January 5, 2021

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative Pain; Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain
• Other Study ID Numbers: HSK21542-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No