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A Phase 1 Study of ISM4808 in Healthy Adult Subjects
Sponsor: TaiGen Biotechnology Co., Ltd.
Summary
This is a Phase I, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), food effect, and QTc effects of single and multiple ascending oral doses of ISM4808 in healthy adult subjects.
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral ISM4808 in Healthy Adult Subjects in China
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
86
Start Date
2026-02-13
Completion Date
2026-12-31
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
ISM4808
ISM4808 administered orally as capsules in single ascending dose and multiple ascending dose regimens, with flexible dosing schedules based on emerging safety and pharmacokinetic data.
Placebo
Matching placebo administered orally under the same conditions as ISM4808.