Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04110886
• Other study ID #: HSK21542-101
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2020
• Est. completion date: January 5, 2021

Study information

• Verified date: March 2020
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 5, 2021
• Est. primary completion date: December 8, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• HSK21542
Single dose, injection, starting dose of 0.2ug escalating up to 20ug
• Placebo
Single dose, injection matching placebo

Locations

Country	Name	City	State
Australia	CMAX Clinical Research Pty Ltd	Adelaide

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Haisco Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

Australia, 

Outcome

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