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Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects

PHASE1RECRUITING

This will be a phase I, randomized, double-blind, placebo-controlled, single-dose escalation study. This study will be conducted in three periods: the screening period , the treatment period and the follow-up period. This study aims to evaluate the pharmacokinetics, target engagement and pharmacodynamic biomarkers of ASC47 in healthy subjects.

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Study details:

The study will consist of five cohorts, each with different doses of ASC47. Cohorts 1 and 2 have 6 subjects, of which 4 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo. Cohorts 3, 4 and 5 have 8 subjects, of which 6 subjects will receive the single dose of ASC47 and 2 subjects will receive matching placebo.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : Yes

Gender eligible for study: All

Things to know

Study dates

Study start: 2024-07-13

Primary completion: 2024-12-01

Study completion finish: 2025-04-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT06427590

Intervention or treatment

DRUG: ASC47

DRUG: Matching placebo

Conditions

• NASH

Condition: NASH
DRUG: ASC47 and other drugs
Herston, Queensland, Australia
Sponsor: Ascletis Pharma (China) Co., Limited

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Nucleus Network

Research sites nearby

Select from list below to view details:

Nucleus Network
Herston, Queensland, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: cohort 1 4 subjects will receive the dose 1 of ASC47, and 2 subjects will receive the placebo.	DRUG: ASC47 single subcutaneous injection of ASC47
EXPERIMENTAL: cohort 2 4 subjects will receive the dose 2 of ASC47, and 2 subjects will receive the placebo.	DRUG: ASC47 single subcutaneous injection of ASC47
EXPERIMENTAL: cohort 3 6 subjects will receive the dose 3 of ASC47, and 2 subjects will receive the placebo.	DRUG: ASC47 single subcutaneous injection of ASC47
EXPERIMENTAL: cohort 4 6 subjects will receive the dose 4 of ASC47, and 2 subjects will receive the placebo.	DRUG: ASC47 single subcutaneous injection of ASC47
EXPERIMENTAL: cohort 5 6 subjects will receive the dose 5 of ASC47, and 2 subjects will receive the placebo	DRUG: ASC47 single subcutaneous injection of ASC47

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	Evaluate the incidence of Serious Adverse Events (SAEs) and Adverse Events (AEs) from after the first dose administration to 57 days.	up to 57 days
ECG QT Interval	Evaluate the ECG QT Interval after single doses of ASC47.	up to 57 days
Blood cell	Evaluate red blood cell count, white blood cell count and platelet count in liter (cells/L) after single doses of ASC47.	up to 57 days
Hematology	Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.	up to 57 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
AUC of ASC47	Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.	up to 57 days
Cmax of ASC47	Evaluate the Peak Plasma Concentration after single doses of ASC47.	up to 57 days
Cmin of ASC47	Evaluate the Minimum Plasma Concentration after single doses of ASC47.	up to 57 days
T1/2 of ASC47	Evaluate the Terminal-Phase Half-Life after single doses of ASC47	up to 57 days
CL/F of ASC47	Evaluate the Apparent Systemic Clearance after single doses of ASC47.	up to 57 days
Vd/F of ASC47	Evaluate the Apparent Volume of Distribution after single doses of ASC47.	up to 57 days
Lipid parameters	Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.	up to 57 days

Frequently Asked Questions

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References

Clinical Trials Gov: Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy Subjects