ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Abivax S.A.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Percentage of patients experiencing at least one Adverse Event
Study Overview
Brief Summary
This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).
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
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- 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
Arms & Interventions
ABX464
50, 100, 150 or 200 mg once a day / Single Administration
Intervention: ABX464 (Drug)
Outcomes
Primary Outcomes
Percentage of patients experiencing at least one Adverse Event
Time Frame: Up to 45 days post dosing
Secondary Outcomes
- 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)