Ascletis announces a posterior report on a Phase I single-dose study of ASC43F for the treatment of NASH at the 2022 American Association for the Study of Liver Disease Annual Meeting

Ascletis Pharmaceuticals Limited (HKSE: 1672, "Ascletis") announced on November 7 that a Phase I single-dose study summary of ASC43F for the treatment of nonalcoholic steatohepatitis (NASH) has been reported
poster at The Liver Meeting® 2022.
The following is a summary of the summary:

: A Phase I single-dose study to evaluate the safety, tolerability, and pharmacokinetics of ASC43F (a fixed-dose combination oral tablet consisting of the thyroid hormone receptor beta agonist ASC41 and the farnesol X receptor agonist ASC42) in healthy subjects

Abstract/poster number: 2314

Category: Nonalcoholic fatty liver disease treatment

Study Design:

ASC43F-101 (NCT05118516) is an open-label, single-dose phase I study
in healthy subjects.
The study planned to enroll eight participants aged 18 to 65 years, requiring men to weigh at least 50 kg and women to weigh at least 45 kg, and a body mass index (BMI) in the range
of 18.
5 to 32 kg/square meter (kg/m2).
Two eligible participants will be enrolled first
.
After the two sentinel subjects were evaluated for safety for 7 days and met the no-stop rule, the remaining six subjects will be enrolled
.

Outcome:

Conclusion:

This phase I study showed that ASC43F showed good tolerability and safety, and the pharmacokinetic (PK) parameters of ASC41/ASC41A and ASC42 in ASC43F were similar
to those of ASC41 and ASC42 as monotherapy.
ASC43F is a fixed-dose combination formulation (FDC) for NASH treatment, which is administered once daily in one tablet at a time, which will improve patient compliance
.