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

Completed · Phase 1

Conditions studied: Healthy Volunteer

In brief

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.

Key facts

Study ID

NCT05118516

Run by

Gannex Pharma Co., Ltd.

People needed

8

Starts

2021-11-01

Expected to finish

2021-12-07

Last updated by the study team

2024-09-27

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.).

Where it is running

• 8307 Gault Lane — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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