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

NASH Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06427590
• Other study ID #: ASC47-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Gannex Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• NASH

Intervention

Drug:
• ASC47
single subcutaneous injection of ASC47
• Matching placebo
single subcutaneous injection of Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gannex Pharma Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	ECG QT Interval	Evaluate the ECG QT Interval after single doses of ASC47.	up to 57 days
Primary	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
Primary	Hematology	Evaluate the levels of glucose, cholesterol, electrolytes after single doses of ASC47.	up to 57 days
Secondary	AUC of ASC47	Evaluate the Area under the plasma concentration versus time curve after single doses of ASC47.	up to 57 days
Secondary	Cmax of ASC47	Evaluate the Peak Plasma Concentration after single doses of ASC47.	up to 57 days
Secondary	Cmin of ASC47	Evaluate the Minimum Plasma Concentration after single doses of ASC47.	up to 57 days
Secondary	T1/2 of ASC47	Evaluate the Terminal-Phase Half-Life after single doses of ASC47	up to 57 days
Secondary	CL/F of ASC47	Evaluate the Apparent Systemic Clearance after single doses of ASC47.	up to 57 days
Secondary	Vd/F of ASC47	Evaluate the Apparent Volume of Distribution after single doses of ASC47.	up to 57 days
Secondary	Lipid parameters	Evaluate the LDL-C, TG, TC, HDL-C after single doses of ASC47.	up to 57 days