Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers

NCT04213196 | Completed Phase 1 DMC

• 1 other identifier: HSK21542-102
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a first-in-human, Phase I, single-dose escalation clinical trial conducted in Chinese healthy volunteers. The safety, tolerability, and PK of HSK21542 injection in healthy volunteers will be evaluated using a randomized, double-blind, placebo-controlled trial design

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• AE/serious AE

  Adverse event/serious adverse event

  From screening up to 3 weeks

• Vital signs: Systolic and Diastolic Blood Pressure

  Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.

  From screening up to 3 weeks

• Ramsay sedation score

  Ramsay sedation score will be collected

  -60 minutes before administration until 24 hours after administration

• Visual analog scale (VAS) addiction score

  VAS addiction score will be collected

  from administration to 24 hours after administration

Secondary Outcomes (7)

• Peak concentration (Cmax)

  -30 minutes before administration until 24 hours after administration

• Area under the concentration-time curve（AUC）

  -30 minutes before administration until 24 hours after administration

• Tmax

  -30 minutes before administration until 24 hours after administration

• Total clearance

  -30 minutes before administration until 24 hours after administration

• Prolactin level

  before administration until 24 hours after administration

Study Arms (9)

HSK21542 0.2 μg/kg（15 min)

EXPERIMENTAL

Healthy volunteers 0.2 μg/kg HSK21542

Drug: HSK21542

HSK21542 0.5 μg/kg

EXPERIMENTAL

Healthy volunteers 0.5 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 1 μg/kg （15min)

EXPERIMENTAL

Healthy volunteers 1 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 1 μg/kg （2min)

EXPERIMENTAL

Healthy volunteers 1 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 0.75 μg/kg

EXPERIMENTAL

Healthy volunteers 0.75 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 1.5 μg/kg

EXPERIMENTAL

Healthy volunteers 1.5 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 2.25 μg/kg

EXPERIMENTAL

Healthy volunteers 2.25 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 3.375 μg/kg

EXPERIMENTAL

Healthy volunteers 3.375 μg/kg HSK21542 or Placebo

Drug: HSK21542

HSK21542 0.2 μg/kg（2min)

EXPERIMENTAL

Healthy volunteers 0.2 μg/kg HSK21542 or Placebo

Drug: HSK21542

Interventions

HSK21542 DRUG

Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

Also known as: HSK21542 0.2 μg/kg

HSK21542 0.2 μg/kg（15 min)

Eligibility Criteria

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

You may qualify if:

• Males and females aged 18-45 years old (inclusive) at screening;
• Male volunteers no less than 50 kg, or female volunteers no less than 45 kg, with body mass index \[BMI\] in the range of 18.0-27.0 kg/m2 (inclusive) at screening;
• Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
• Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
• Able to communicate with the investigator and to follow all requirements of the study, and willing to be admitted into the phase I clinical facility.

You may not qualify if:

• Those who have suffered or are currently suffering from any clinical serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry and metabolic abnormality or any other disease or physiological condition that can interfere with the results;
• Physical examination, vital sign monitoring, ECG examination, chest anteroposterior and lateral radiographs, laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function, thyroid function, blood pregnancy (only for female subjects) during screening period, and the researcher judged that the abnormality had clinical significance;
• People with positive hepatitis B surface antigen, positive hepatitis C antibody, positive Treponema pallidum antibody, or positive AIDS virus antibody test;
• Patients with QTcF\>450 ms in ECG examination during screening;
• Allergic constitution: such as those who are allergic to two or more drugs and foods; Or those who are allergic to any ingredient in this product and auxiliary materials; (Auxiliary materials: glacial acetic acid, sodium acetate, water for injection)
• Those who cannot tolerate venipuncture and/or have a history of blood and needle sickness;
• Those who have drunk too much tea, grapefruit, coffee, caffeinated or grapefruit drinks for a long time (more than 8 cups a day, 1 cup=250mL);
• Those who have a history of alcohol abuse within 3 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit=12 ounces or 360 mL of beer, 1.5 ounces or 45 mL of spirits with 40% alcohol content, 5 ounces or 150 mL of wine), or those who have positive alcohol breath test;
• Volunteers with a positive urine nicotine test;
• Volunteers with drug abuse or dependence, or with a positive urine drugs of abuse test;
• Those who have used any prescription medicine, over-the-counter medicine, Chinese herbal medicine and health care products within 14 days
• Blood donation or loss of blood \> 450 mL within the past 3 months;
• Participation in any clinical trials within the past 3 months;
• Volunteers who plan to become pregnant within the next 6 months;
• Any other factors judged by the investigator to be unsuitable for participating in this study.

Sponsors & Collaborators

• Sichuan Haisco Pharmaceutical Group Co., Ltd: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Related Publications (1)

• Zollner C, Mousa SA, Fischer O, Rittner HL, Shaqura M, Brack A, Shakibaei M, Binder W, Urban F, Stein C, Schafer M. Chronic morphine use does not induce peripheral tolerance in a rat model of inflammatory pain. J Clin Invest. 2008 Mar;118(3):1065-73. doi: 10.1172/JCI25911.

  PMID: 18246198 RESULT

Study Officials

• Min Yan, PhD

  The Second Affiliated Hospital of Zhejiang University Medical College

  STUDY DIRECTOR

• Hong-gang Lou, PhD

  The Second Affiliated Hospital of Zhejiang University Medical College

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 25, 2019
• First Posted: December 30, 2019
• Study Start: January 9, 2020
• Primary Completion: September 6, 2020
• Study Completion: December 7, 2020
• Last Updated: February 22, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)