Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

NCT04110886 | Completed Phase 1

• 1 other identifier: HSK21542-101
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Chronic Pain

Keywords

Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Cmax

  From the start of administration to 24 hours after administration

• Tmax

  From the start of administration to 24 hours after administration

• t1/2

  From the start of administration to 24 hours after administration

• AUC0-t

  From the start of administration to 24 hours after administration

• AUC0-inf

  From the start of administration to 24 hours after administration

Study Arms (2)

HSK21542 single ascending doses

EXPERIMENTAL

Drug: HSK21542

Placebo single dose

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HSK21542 DRUG

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

HSK21542 single ascending doses

Placebo DRUG

Single dose, injection matching placebo

Placebo single dose

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead

Study Sites (1)

CMAX Clinical Research Pty Ltd

Adelaide, Australia

Location

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Paul Wabnitz, PhD

  CMAX Clinical Research Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2019
• First Posted: October 1, 2019
• Study Start: July 2, 2020
• Primary Completion: December 8, 2020
• Study Completion: January 5, 2021
• Last Updated: February 9, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)