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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06427590




Registration number
NCT06427590
Ethics application status
Date submitted
10/05/2024
Date registered
24/05/2024
Date last updated
19/09/2024

Titles & IDs
Public title
Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects
Scientific title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 Injection for Subcutaneous Use in Healthy Subjects
Secondary ID [1] 0 0
ASC47-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
NASH 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ASC47
Treatment: Drugs - Matching placebo

Experimental: cohort 1 - 4 subjects will receive the dose 1 of ASC47, and 2 subjects will receive the placebo.

Experimental: cohort 2 - 4 subjects will receive the dose 2 of ASC47, and 2 subjects will receive the placebo.

Experimental: cohort 3 - 6 subjects will receive the dose 3 of ASC47, and 2 subjects will receive the placebo.

Experimental: cohort 4 - 6 subjects will receive the dose 4 of ASC47, and 2 subjects will receive the placebo.

Experimental: cohort 5 - 6 subjects will receive the dose 5 of ASC47, and 2 subjects will receive the placebo


Treatment: Drugs: ASC47
single subcutaneous injection of ASC47

Treatment: Drugs: Matching placebo
single subcutaneous injection of Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Timepoint [1] 0 0
up to 57 days
Primary outcome [2] 0 0
ECG QT Interval
Timepoint [2] 0 0
up to 57 days
Primary outcome [3] 0 0
Blood cell
Timepoint [3] 0 0
up to 57 days
Primary outcome [4] 0 0
Hematology
Timepoint [4] 0 0
up to 57 days
Secondary outcome [1] 0 0
AUC of ASC47
Timepoint [1] 0 0
up to 57 days
Secondary outcome [2] 0 0
Cmax of ASC47
Timepoint [2] 0 0
up to 57 days
Secondary outcome [3] 0 0
Cmin of ASC47
Timepoint [3] 0 0
up to 57 days
Secondary outcome [4] 0 0
T1/2 of ASC47
Timepoint [4] 0 0
up to 57 days
Secondary outcome [5] 0 0
CL/F of ASC47
Timepoint [5] 0 0
up to 57 days
Secondary outcome [6] 0 0
Vd/F of ASC47
Timepoint [6] 0 0
up to 57 days
Secondary outcome [7] 0 0
Lipid parameters
Timepoint [7] 0 0
up to 57 days

Eligibility
Key inclusion criteria
Key inclusion Criteria:

* Subject have provided informed consent before initiation of any study-specific procedures
* Healthy male subjects or female subjects, between 18 and 55 years of age (inclusive).
* Females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures, eg.

Key exclusion Criteria:

* Have a clinically relevant acute or chronic medical condition or disease of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, or dermatologic systems as assessed by the investigator.
* Have any current or historical disease or disorder of the hematological system or significant liver disease or family history of bleeding/platelet disorders.
* Have a history of cancer (other than basal cell or squamous cell cancer of the skin which is fully excised), rheumatologic disease or blood dyscrasia.
* Have a history of febrile illness within 14 days prior to screening.
* Have a positive alcohol or drug screen at Screening or have a history of alcohol or drug abuse within the past 1 years.
* Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
* Have used prescription drugs (other than hormone replacement therapy and medications for contraceptive purpose) within 14 days prior to the first dose of Investigational product.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria

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 administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
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
13/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Nucleus Network - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ascletis Pharma (China) Co., Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

No information has been provided regarding IPD availability


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/NCT06427590