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:
2025-12-24 @ 5:43 PM
Ignite Modification Date:
2025-12-24 @ 5:43 PM
NCT ID:
NCT03935568
Brief Summary:
This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.
Detailed Description:
This is a Phase 1, double-blind trial in two parts. A single ascending dose study in approximately 3 cohorts receiving a single oral dose of PU-AD or placebo and a multiple ascending dose study in 2 cohorts. Each subject in all cohorts will be administered an oral solution of PU AD or placebo under fasting conditions. Each cohort will contain subjects randomized to active treatment or placebo, evaluating safety and tolerance.
Study:
NCT03935568
Study Brief:
Protocol Section:
NCT03935568