Clinical trial NCT04110886: Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postoperative Pain
Chronic Pain
Keywords: Pain
Postoperative Pain
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: Between screening and 7-9 days after dosing
measure: Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters
timeFrame: Between screening and 7-9 days after dosing
Secondary outcomes:
measure: Cmax
timeFrame: From the start of administration to 24 hours after administration
measure: Tmax
timeFrame: From the start of administration to 24 hours after administration
measure: t1/2
timeFrame: From the start of administration to 24 hours after administration
measure: AUC0-t
timeFrame: From the start of administration to 24 hours after administration
measure: AUC0-inf
timeFrame: From the start of administration to 24 hours after administration
measure: CL
timeFrame: From the start of administration to 24 hours after administration
measure: Vd
timeFrame: From the start of administration to 24 hours after administration
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX Clinical Research Pty Ltd
Study officials:
affiliation: CMAX Clinical Research Pty Ltd
name: Paul Wabnitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: