HANGZHOU and SHAOXING, China, November 6, 2022 /PRNewswire/ — Ascletis Pharma Inc. (HKEX:1672, “Ascletis”) announced today that the summary of a Phase I single dose study of ASC43F for non alcoholic Steatohepatitis (NASH) was reported at the Liver Meeting® 2022 by the American Association for the Study of Liver Diseases (AASLD) as a poster presentation. The summary of the abstract is presented as follows:
Title: A phase I single-dose study to evaluate the safety, tolerability, and pharmacokinetics of ASC43F, a fixed-dose oral tablet combination of ASC41, a thyroid hormone receptor beta agonist, and ASC42, a farnesoid X receptor agonist, in healthy volunteers
Abstract/Poster number: 2314
Category: NAFLD therapy
Study design:
ASC43F-101 (NCT05118516) is an open-label, single-dose, phase I study in healthy volunteers. Eight subjects aged 18 to 65 years, weighing at least 50 kg for males and at least 45 kg for females and having a body mass index (BMI) in the range of 18.5 to 32 kilograms per square meter (kg/m2) should be included in this study. Two eligible subjects would be enrolled first. After completing the 7-day safety assessment of the first two Sentinel subjects and no stopping rule, the remaining 6 subjects would be enrolled.
Conclusion
This phase I study showed that ASC43F had good tolerability and safety profiles and the pharmacokinetic (PK) parameters of ASC41/ASC41A and ASC42 from ASC43F were similar to those of ASC41 and ASC42 as monotherapy. ASC43F is a…
