Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
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)
Interventions
DRUGABX464
Single Administration
Sponsors
Abivax S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients experiencing at least one Adverse Event | Up to 45 days post dosing |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
France
Outcome results
None listed