Skip to main content
OpenTrials
Completed

NCT Number: NCT02792686

ABX464 First in Man Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Centre Cap

Montpellier, France

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABX464

Drug

Single Administration

Primary outcomes

  1. Percentage of patients experiencing at least one Adverse Event

    Time frame: Up to 45 days post dosing

Secondary outcomes

  1. Peak Plasma Concentrations (Cmax) of ABX464 and metabolite

    Time frame: Up to 45 days post dosing

  2. Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite

    Time frame: Up to 45 days post dosing

Sponsors and collaborators

Lead sponsor

Abivax S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jun 7, 2016
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.