NCT07415304

A Phase 1 Study of ISM4808 in Healthy Adult Subjects

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 86 (estimated)
• Sponsor: TaiGen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study consists of two parts, Part 1 includes single ascending dose (SAD) and food effect (FE) assessments, FE assessments will be conducted in a selected dose cohort from the single ascending dose phase, using the same subjects after an appropriate washout period, AND Part 2 includes multiple ascending dose (MAD) evaluations. Safety, PK, PD, and concentration-QTc relationship will be assessed across dose levels. Dose escalation decisions will be based on the review of available safety, tolerability, and pharmacokinetic data by a Safety Monitoring Committee.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-02-13
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2026-02-17
• Last updated: 2026-02-17