ABX464 First in Man Study
ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study
Lead SponsorAbivax S.A.
StatusCompleted No Results Posted
This study is an open label, parallel group, single ascending dose, exploratory study performed in a single site (Centre Cap, Montpellier, France).
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)
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