ABX464 First in Man Study

Status Completed

Clinical Trial Summary

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

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Healthy Volunteers

Clinical Trial Details

NCT number	NCT02792686
Study type	Interventional
Source	Abivax S.A.
Contact
Status	Completed
Phase	Phase 1
Start date	March 2014
Completion date	July 2014

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