Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07415304
Brief 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.
Study:
NCT07415304
Study Brief:
Protocol Section:
NCT07415304