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 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT07107802
Brief Summary:
The main objective of this study is to assess the safety and tolerability of intravenously administered ATX101 in healthy adults following single ascending doses of ATX101. The pharmacokinetic profile of ATX101 and its metabolites will also be investigated.
Detailed Description:
This is a single-center, double-blinded, placebo-controlled, phase I, single ascending dose study in healthy participants. A maximum of three ATX101 dose levels are pre-planned to be investigated in three separate sequential cohorts. Each of these cohorts will consist of 8 healthy participants (6 participants randomized to ATX101 and 2 to placebo). The study will consist of:
* a screening period, within 7 to 21 days before investigational product administration (Day -21 to Day -7),
* a treatment period, including admission to confinement, 3-night confinement, and discharge from confinement.
* a follow-up period, which includes two ambulatory follow-up visits (Day 4 and Day 7).
Total duration of study participation for each participant will be approximately 4 weeks.
Study:
NCT07107802
Study Brief:
Protocol Section:
NCT07107802