Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects

NCT ID: NCT05118516

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2021-12-07

Brief Summary

This is a phase 1, open-label study in healthy adults. This study is aimed at evaluating the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose combination (FDC) and single dose tablet containing ASC41, a THR β agonist and ASC42, an FXR agonist in healthy subjects.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Experimental

ASC43F for all subjects under the fasted state.

Group Type: EXPERIMENTAL

ASC43F

Intervention Type: DRUG

One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.

Interventions

ASC43F

One dose of oral ASC43F FDC tablet containing ASC41 5mg and ASC42 15mg.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy male and female subjects between 18 to 65 years of age.
• Subjects must weigh at least 50 kg (110 pounds [lbs.]) for men, and at least 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-32 kilogram per meter square (kg/m2).
• Physical examination and vital signs are within normal range or slightly abnormal.

Exclusion Criteria

• Any surgical or medical condition which in the opinion of the investigator, might significantly alter the absorption, distribution, metabolism, or excretion of drugs.
• Abnormal clinical or laboratory findings that indicate diseases including but not limited to renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic disease.
• History or current electrocardiogram (ECG) abnormalities, arrhythmias or heart valve diseases.
• History of viral hepatitis or HIV
• History of drug or food allergies that caused severe hypersensitivity reactions or anaphylaxis.).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Gannex Pharma Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

8307 Gault Lane

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ASC43F-101

Identifier Type: -

Identifier Source: org_study_id