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

Gannex Pharma Co., Ltd.1 site in 1 country8 target enrollmentNovember 1, 2021

ConditionsHealthy Volunteer

InterventionsASC43F

DrugsASC43F

Overview

Phase: Phase 1
Intervention: ASC43F
Conditions: Healthy Volunteer
Sponsor: Gannex Pharma Co., Ltd.
Enrollment: 8
Locations: 1
Primary Endpoint: Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 1, 2021

End Date

December 7, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gannex Pharma Co., Ltd.

Responsible Party

Sponsor

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.).

Arms & Interventions

Experimental

ASC43F for all subjects under the fasted state.

Intervention: ASC43F

Outcomes

Primary Outcomes

Safety and tolerability of ASC43F evaluated by incidence of treatment emergent adverse events (TEAEs).

Time Frame: Baseline to day 7

Secondary Outcomes

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)