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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sichuan Haisco Pharmaceutical Group Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 6, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 7, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 25, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 25, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2019

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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