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

Gannex Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: ASC43F

Study type

Interventional

Funder types

Industry

Identifiers

NCT05118516

ASC43F-101

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.).