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Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04110886
Recruitment Status : Recruiting
First Posted : October 1, 2019
Last Update Posted : March 26, 2020
Sponsor:
Collaborator:
CMAX Clinical Research Pty Ltd
Information provided by (Responsible Party):
Haisco Pharmaceutical Group Co., Ltd. ( Sichuan Haisco Pharmaceutical Group Co., Ltd )

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.


Condition or disease Intervention/treatment Phase
Postoperative Pain Chronic Pain Drug: HSK21542 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 3, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : July 2020

Arm Intervention/treatment
Experimental: HSK21542 single ascending doses Drug: HSK21542
Single dose, injection, starting dose of 0.2ug escalating up to 20ug

Placebo Comparator: Placebo single dose Drug: Placebo
Single dose, injection matching placebo




Primary Outcome Measures :
  1. Number of subjects with adverse events [ Time Frame: Between screening and 7-9 days after dosing ]
    To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events

  2. Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters [ Time Frame: Between screening and 7-9 days after dosing ]
    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


Secondary Outcome Measures :
  1. Cmax [ Time Frame: From the start of administration to 24 hours after administration ]
    Maximum (peak) plasma drug concentration

  2. Tmax [ Time Frame: From the start of administration to 24 hours after administration ]
    Time to reach maximum (peak) plasma concentration following drug administration

  3. t1/2 [ Time Frame: From the start of administration to 24 hours after administration ]
    Elimination half-life

  4. AUC0-t [ Time Frame: From the start of administration to 24 hours after administration ]
    Area under the plasma concentration-time curve from time zero to time t.

  5. AUC0-inf [ Time Frame: From the start of administration to 24 hours after administration ]
    Area under the plasma concentration-time curve from time zero to infinity

  6. CL [ Time Frame: From the start of administration to 24 hours after administration ]
    Apparent total body clearance of the drug from plasma

  7. Vd [ Time Frame: From the start of administration to 24 hours after administration ]
    Apparent volume of distribution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110886


Contacts
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Contact: zhenghong Xia 86 ext 18964573960 xiazhenghong@haisco.com

Locations
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Australia
CMAX Clinical Research Pty Ltd Recruiting
Adelaide, Australia
Contact: Xuliang Li    181 8069 7260    lixuliang@haisco.com   
Sponsors and Collaborators
Sichuan Haisco Pharmaceutical Group Co., Ltd
CMAX Clinical Research Pty Ltd
Investigators
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Principal Investigator: Paul Wabnitz, PhD CMAX Clinical Research Pty Ltd
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Responsible Party: Sichuan Haisco Pharmaceutical Group Co., Ltd
ClinicalTrials.gov Identifier: NCT04110886    
Other Study ID Numbers: HSK21542-101
First Posted: October 1, 2019    Key Record Dates
Last Update Posted: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haisco Pharmaceutical Group Co., Ltd. ( Sichuan Haisco Pharmaceutical Group Co., Ltd ):
Pain
Postoperative Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Chronic Pain
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations