ABX464 First in Man Study

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABX464

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • Centre Cap

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria:

• Subject with any on-going infection or disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ABX464; 50, 100, 150 or 200 mg once a day / Single Administration	Drug: ABX464; Single Administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients experiencing at least one Adverse Event	Up to 45 days post dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abivax S.A.

Publications and helpful links

General Publications

• Scherrer D, Rouzier R, Noel Barrett P, Steens JM, Gineste P, Murphy RL, Tazi J, Ehrlich HJ. Pharmacokinetics and tolerability of ABX464, a novel first-in-class compound to treat HIV infection, in healthy HIV-uninfected subjects. J Antimicrob Chemother. 2017 Mar 1;72(3):820-828. doi: 10.1093/jac/dkw458.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: May 30, 2016
• First Submitted That Met QC Criteria: June 2, 2016
• First Posted (Estimated): June 7, 2016

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 16, 2024
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Healthy Volunteers
• Other Study ID Numbers: ABX464-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO