ABX464 First in Man Study

• Sponsor: Abivax S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02792686
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arm: 1
• Duration (Months): 4
• Patients Per Site Per Month: 6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: ABX464	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of patients experiencing at least one Adverse Event [Up to 45 days post dosing]

Secondary Outcome Measures

1. Peak Plasma Concentrations (Cmax) of ABX464 and metabolite [Up to 45 days post dosing]

2. Area Under the Curve (AUC) of Plasma Concentrations of ABX464 and metabolite [Up to 45 days post dosing]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre Cap	Montpellier		France

Sponsors and Collaborators

• Abivax S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abivax S.A.
• ClinicalTrials.gov Identifier: NCT02792686
• Other Study ID Numbers: ABX464-001
• First Posted: Jun 7, 2016
• Last Update Posted: Jun 7, 2016
• Last Verified: May 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Abivax S.A.: Healthy Volunteers

Study Results

No Results Posted as of Jun 7, 2016