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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04110886




Registration number
NCT04110886
Ethics application status
Date submitted
27/08/2019
Date registered
1/10/2019
Date last updated
9/02/2021

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
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
Timepoint [2] 0 0
Between screening and 7-9 days after dosing
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [3] 0 0
t1/2
Timepoint [3] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [4] 0 0
AUC0-t
Timepoint [4] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [5] 0 0
AUC0-inf
Timepoint [5] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [6] 0 0
CL
Timepoint [6] 0 0
From the start of administration to 24 hours after administration
Secondary outcome [7] 0 0
Vd
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
Sex
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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/01/2021
Sample size
Target
Accrual to date
Final
120
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

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/ct2/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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04110886