NCT02792686

ABX464 First in Man Study

ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Abivax S.A. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).

Detailed description

This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France). Six subjects per dose group were enrolled into 1 of 4 groups with escalating doses of ABX464 (50, 100, 150 and 200 mg). For each dose group, a first subject was treated, if no adverse event (AE) occurred, a second subject was dosed one hour later. The four last subjects were dosed the day after if no clinically significant AE occurred. Escalation to the following dose level was decided after review of PK and safety data (laboratory results, ECG, vital signs and AEs)

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ABX464	Single Administration

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2016-06-07
• Last updated: 2024-05-17

Locations

1 site across 1 country: France