ABX464 First in Man Study

ABIVAX

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: ABX464

Study type: Interventional

Funder types: Industry

Identifiers

NCT02792686

ABX464-001

Details and patient eligibility

About

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

Full 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)

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

ABX464

Experimental group

Description:

50, 100, 150 or 200 mg once a day / Single Administration

Treatment:

Drug: ABX464