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CompletedNCT04213196Updated Feb 22, 2023

Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers

A Phase 1 interventional study of HSK21542 and HSK21542 in Healthy Volunteers, sponsored by Sichuan Haisco Pharmaceutical Group Co., Ltd. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-22.

Sponsored by Sichuan Haisco Pharmaceutical Group Co., Ltd · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
66
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd is the lead sponsor of 30 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Males and females aged 18-45 years old (inclusive) at screening;
  2. 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;
  3. Healthy volunteers, as assessed by the investigator based on past medical history, comprehensive physical examination, vital signs, and specified tests and examinations.
  4. Fully understand the nature, purpose, and potential benefits, inconveniences and risks of the trial. Understand the study procedure and voluntarily provide written informed consent.
  5. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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;
  2. 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;
  3. People with positive hepatitis B surface antigen, positive hepatitis C antibody, positive Treponema pallidum antibody, or positive AIDS virus antibody test;
  4. Patients with QTcF>450 ms in ECG examination during screening;
  5. 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)
  6. Those who cannot tolerate venipuncture and/or have a history of blood and needle sickness;
  7. 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);
  8. 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;
  9. Volunteers with a positive urine nicotine test;
  10. Volunteers with drug abuse or dependence, or with a positive urine drugs of abuse test;
  11. Those who have used any prescription medicine, over-the-counter medicine, Chinese herbal medicine and health care products within 14 days
  12. Blood donation or loss of blood > 450 mL within the past 3 months;
  13. Participation in any clinical trials within the past 3 months;
  14. Volunteers who plan to become pregnant within the next 6 months;
  15. Any other factors judged by the investigator to be unsuitable for participating in this study.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    HSK21542 0.2 μg/kg（15 min)

    Healthy volunteers 0.2 μg/kg HSK21542

    Drug: HSK21542

  • Experimental
    HSK21542 0.5 μg/kg

    Healthy volunteers 0.5 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 1 μg/kg （15min)

    Healthy volunteers 1 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 1 μg/kg （2min)

    Healthy volunteers 1 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 0.75 μg/kg

    Healthy volunteers 0.75 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 1.5 μg/kg

    Healthy volunteers 1.5 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 2.25 μg/kg

    Healthy volunteers 2.25 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 3.375 μg/kg

    Healthy volunteers 3.375 μg/kg HSK21542 or Placebo

    Drug: HSK21542

  • Experimental
    HSK21542 0.2 μg/kg（2min)

    Healthy volunteers 0.2 μg/kg HSK21542 or Placebo

    Drug: HSK21542

Interventions

  • DrugHSK21542

    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

  • DrugHSK21542

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

    Also known as: HSK21542 0.5 μg/kg

  • DrugHSK21542

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

    Also known as: HSK21542 1 μg/kg

  • DrugHSK21542

    Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.

    Also known as: HSK21542 1 μg/kg

  • DrugHSK21542

    Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

    Also known as: HSK21542 0.75 μg/kg

  • DrugHSK21542

    Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

    Also known as: HSK21542 1.5 μg/kg

  • DrugHSK21542

    Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

    Also known as: HSK21542 2.25 μg/kg

  • DrugHSK21542

    Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.

    Also known as: HSK21542 3.375 μg/kg

  • DrugHSK21542

    Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.

    Also known as: HSK21542 0.2 μg/kg

06

What researchers measure

Primary outcomes

  1. AE/serious AE

    Adverse event/serious adverse event

    Time frame: From screening up to 3 weeks

  2. Vital signs: Systolic and Diastolic Blood Pressure

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

    Time frame: From screening up to 3 weeks

  3. Ramsay sedation score

    Ramsay sedation score will be collected

    Time frame: -60 minutes before administration until 24 hours after administration

  4. Visual analog scale (VAS) addiction score

    VAS addiction score will be collected

    Time frame: from administration to 24 hours after administration

Secondary outcomes

  1. Peak concentration (Cmax)

    Cmax（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.

    Time frame: -30 minutes before administration until 24 hours after administration

  2. Area under the concentration-time curve（AUC）

    AUC（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.

    Time frame: -30 minutes before administration until 24 hours after administration

  3. Tmax

    time to peak observed

    Time frame: -30 minutes before administration until 24 hours after administration

  4. Total clearance

    Total clearance

    Time frame: -30 minutes before administration until 24 hours after administration

  5. Prolactin level

    Prolactin level will be collected

    Time frame: before administration until 24 hours after administration

  6. Antidiuretic hormone level

    Antidiuretic hormone level will be collected

    Time frame: before administration until 24 hours after administration

  7. Urine volume

    Urine volume will be collected

    Time frame: before administration until 24 hours after administration

07

Study locations

1 site
  • Second Affiliated Hospital of Zhejiang University School of Medicine
    Hangzhou, China
08

References and documents

Publications

  • 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. PubMed 18246198 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04213196
Lead sponsor
Sichuan Haisco Pharmaceutical Group Co., Ltd
Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Responsible party
Sponsor
First posted
Dec 30, 2019
Start date
Jan 9, 2020
Primary completion
Sep 6, 2020
Completion
Dec 7, 2020
Last update
Feb 22, 2023

Study contacts

Min Yan, PhD
study director · The Second Affiliated Hospital of Zhejiang University Medical College
Hong-gang Lou, PhD
study director · The Second Affiliated Hospital of Zhejiang University Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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