Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers

February 20, 2023 updated by: Sichuan Haisco Pharmaceutical Group Co., Ltd

A Phase I Clinical Study Evaluating the Safety, Tolerability and Pharmacokinetics of HSK21542 in Healthy Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HSK21542 0.2 μg/kg（15 min)
Healthy volunteers 0.2 μg/kg HSK21542
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 0.5 μg/kg
Healthy volunteers 0.5 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 1 μg/kg （15min)
Healthy volunteers 1 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 1 μg/kg （2min)
Healthy volunteers 1 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 0.75 μg/kg
Healthy volunteers 0.75 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 1.5 μg/kg
Healthy volunteers 1.5 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 2.25 μg/kg
Healthy volunteers 2.25 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 3.375 μg/kg
Healthy volunteers 3.375 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg
Experimental: HSK21542 0.2 μg/kg（2min)
Healthy volunteers 0.2 μg/kg HSK21542 or Placebo
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.2 μg/kg
Drug: HSK21542
Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.5 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 1 μg/kg
Drug: HSK21542
Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 0.75 μg/kg
Drug: HSK21542
Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 1.5 μg/kg
Drug: HSK21542
Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 2.25 μg/kg
Drug: HSK21542
Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
Other Names:
  • HSK21542 3.375 μg/kg
Drug: HSK21542
Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
Other Names:
  • HSK21542 0.2 μg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AE/serious AE
Time Frame: From screening up to 3 weeks
Adverse event/serious adverse event
From screening up to 3 weeks
Vital signs: Systolic and Diastolic Blood Pressure
Time Frame: From screening up to 3 weeks
Vital signs (Systolic and Diastolic Blood Pressure) will be collected in healthy volunteers.
From screening up to 3 weeks
Ramsay sedation score
Time Frame: -60 minutes before administration until 24 hours after administration
Ramsay sedation score will be collected
-60 minutes before administration until 24 hours after administration
Visual analog scale (VAS) addiction score
Time Frame: from administration to 24 hours after administration
VAS addiction score will be collected
from administration to 24 hours after administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: -30 minutes before administration until 24 hours after administration
time to peak observed
-30 minutes before administration until 24 hours after administration
Peak concentration (Cmax)
Time Frame: -30 minutes before administration until 24 hours after administration
Cmax（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.
-30 minutes before administration until 24 hours after administration
Area under the concentration-time curve（AUC）
Time Frame: -30 minutes before administration until 24 hours after administration
AUC（a measure of the body's exposure to HSK21542）will be calculated in healthy volunteers.
-30 minutes before administration until 24 hours after administration
Total clearance
Time Frame: -30 minutes before administration until 24 hours after administration
Total clearance
-30 minutes before administration until 24 hours after administration
Prolactin level
Time Frame: before administration until 24 hours after administration
Prolactin level will be collected
before administration until 24 hours after administration
Antidiuretic hormone level
Time Frame: before administration until 24 hours after administration
Antidiuretic hormone level will be collected
before administration until 24 hours after administration
Urine volume
Time Frame: before administration until 24 hours after administration
Urine volume will be collected
before administration until 24 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sichuan Haisco Pharmaceutical Group Co., Ltd

Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2020

Primary Completion (Actual)

September 6, 2020

Study Completion (Actual)

December 7, 2020

Study Registration Dates

First Submitted

December 25, 2019

First Submitted That Met QC Criteria

December 25, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • HSK21542-102

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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