NCT07107802

Phase 1 Single Ascending Dose Study With ATX101

A Phase 1, Single Ascending Dose Study, to Assess the Safety and Pharmacokinetics of Intravenous ATX101 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Aurobac Therapeutics SAS · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	ATX101	Single intravenous dose
DRUG	Placebo	Single intravenous dose

Timeline

• Start date: 2025-07-19
• Primary completion: 2025-10-24
• Completion: 2025-10-24
• First posted: 2025-08-06
• Last updated: 2025-11-28

Locations

1 site across 1 country: Portugal