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

A Phase 1, Open-label, Single-dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ASC43F, a Fixed-dose Combination (FDC) Oral Tablet Containing ASC41, a THR β Agonist and ASC42, an FXR Agonist in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05118516

Enrollment

Registered

2021-11-12

Start date

2021-11-01

Completion date

2021-12-07

Last updated

2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

ASC43F, Phase 1, Thyroid hormone receptor beta agonist, FXR agonist, ASC41, ASC42

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.

Interventions

DRUGASC43F

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.).

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).	Baseline to day 7

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026