ABX464 First in Man Study

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: ABX464

• Registration Number: NCT02792686
• Lead Sponsor: Abivax S.A.

Brief 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)

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-05
• Study First Submitted: 2016-05-30
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Last Update Submitted: 2024-05-16
• Last Update Posted: 2024-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Healthy volunteers
• Subject in good health on the basis of medical history, physical examination, vital signs, electrocardiogram (ECG) and routine laboratory safety tests
• Subject with a BMI of 18 27kg/m²
• Non smokers or light smokers of less than 10 cigarettes per day
• Having given their written informed consent

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Exclusion Criteria

• Subject with any on-going infection or disease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ABX464	ABX464	50, 100, 150 or 200 mg once a day / Single Administration

Primary Outcome Measures

Name	Time	Method
Percentage of patients experiencing at least one Adverse Event	Up to 45 days post dosing

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentrations (Cmax) of ABX464 and metabolite	Up to 45 days post dosing
Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite	Up to 45 days post dosing

Trial Locations

Locations (1)

Centre Cap; 🇫🇷 Montpellier, France