Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects
- Registration Number
- NCT05118516
- Lead Sponsor
- Gannex Pharma Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
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.).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental ASC43F ASC43F for all subjects under the fasted state.
- Primary Outcome Measures
Name Time Method Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs). Baseline to day 7
- Secondary Outcome Measures
Name Time Method To evaluate the pharmacokinetics as assessed by Cmax (Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects Baseline to day 4 To evaluate the pharmacokinetics as assessed by Area Under the Curve (AUC) of ASC43F tablet following a single fixed oral dose in healthy subjects Baseline to day 4 To evaluate the pharmacokinetics as assessed by Tmax (Time to Max Concentration) of ASC43F tablet following a single fixed oral dose in healthy subjects Baseline to day 4
Trial Locations
- Locations (1)
8307 Gault Lane
🇺🇸San Antonio, Texas, United States