Phase 1Not yet recruiting
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
- Sponsor
- TaiGen Biotechnology Co., Ltd. (Industry)
- Enrolment
- 86 planned
- Conditions
- Healthy Volunteers
- Interventions
- ISM4808; Placebo
- Ages
- adults
- Registry
- NCT07415304
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Number of Participants With treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
History
Study completion expected
Primary completion expected
Registered
Started