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:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT05032560
Brief Summary:
The study consists of Part A, a randomized double-blind, single-ascending-dose study, and Part B, a randomized, double-blind, semi-sequential, escalating multiple-dose study, in healthy Japanese volunteers.
Detailed Description:
Part A includes the following two dose regimen groups:
* 25 mg dose regimen group: ABX464 25 mg or placebo
* 50 mg dose regimen group: ABX464 50 mg or placebo In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).
Part B includes the following two dose regimen groups:
* 25 mg dose regimen group: ABX464 25 mg or placebo for 28 days
* 50 mg dose regimen group: ABX464 50 mg or placebo for 28 days
In each dose regimen group, 12 subjects will be randomly assigned, according to a 3:1 ratio, to receive either ABX464 (9 subjects) or its matching placebo (3 subjects).
Study:
NCT05032560
Study Brief:
Protocol Section:
NCT05032560