ABX464 First in Man Study

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792686
• Other study ID #: ABX464-001
• Status: Completed
• Phase: Phase 1
• Start date: March 2014
• Est. completion date: July 2014

Study information

• Verified date: May 2016
• Source: Abivax S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• ABX464
Single Administration

Locations

Country	Name	City	State
France	Centre Cap	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
Abivax S.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients experiencing at least one Adverse Event		Up to 45 days post dosing
Secondary	Peak Plasma Concentrations (Cmax) of ABX464 and metabolite		Up to 45 days post dosing
Secondary	Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite		Up to 45 days post dosing