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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04110886
Ethics application status
Date submitted
27/08/2019
Date registered
1/10/2019

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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04110886