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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04110886




Registration number
NCT04110886
Ethics application status
Date submitted
27/08/2019
Date registered
1/10/2019
Date last updated
26/03/2020

Titles & IDs
Public title
Safety, Tolerability, and Pharmacokinetics of HSK21542 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
HSK21542-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative Pain 0 0
Chronic Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HSK21542
Treatment: Drugs - Placebo

Experimental: HSK21542 single ascending doses -

Placebo Comparator: Placebo single dose -


Treatment: Drugs: HSK21542
Single dose, injection, starting dose of 0.2ug escalating up to 20ug

Treatment: Drugs: Placebo
Single dose, injection matching placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of subjects with adverse events - To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events
Timepoint [1] 0 0
Between screening and 7-9 days after dosing
Primary outcome [2] 0 0
Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters - 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
Timepoint [2] 0 0
Between screening and 7-9 days after dosing
Secondary outcome [1] 0 0
Cmax - Maximum (peak) plasma drug concentration
Timepoint [1] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [2] 0 0
Tmax - Time to reach maximum (peak) plasma concentration following drug administration
Timepoint [2] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [3] 0 0
t1/2 - Elimination half-life
Timepoint [3] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [4] 0 0
AUC0-t - Area under the plasma concentration-time curve from time zero to time t.
Timepoint [4] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [5] 0 0
AUC0-inf - Area under the plasma concentration-time curve from time zero to infinity
Timepoint [5] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [6] 0 0
CL - Apparent total body clearance of the drug from plasma
Timepoint [6] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [7] 0 0
Vd - Apparent volume of distribution
Timepoint [7] 0 0
From the start of administration to 24 hours after administration

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 0 0
- Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sichuan Haisco Pharmaceutical Group Co., Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
CMAX Clinical Research Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT04110886
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Paul Wabnitz, PhD
Address 0 0
CMAX Clinical Research Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
zhenghong Xia
Address 0 0
Country 0 0
Phone 0 0
86
Fax 0 0
Email 0 0
xiazhenghong@haisco.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04110886