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NOT YET RECRUITING
NCT07415304
PHASE1

A Phase 1 Study of ISM4808 in Healthy Adult Subjects

Sponsor: TaiGen Biotechnology Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

Placebo

Matching placebo administered orally under the same conditions as ISM4808.