Trial | NCT02792686  Report issue

Title

ABX464 First in Man Study
ABX464 First in Man, Open Label, Parallel Group, Single Ascending Dose Study

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
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)
Study Started
Mar 31
2014
Primary Completion
Jul 31
2014
Study Completion
Jul 31
2014
Last Update
Jun 07
2016
Estimate

Drug ABX464

Single Administration

ABX464 Experimental

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

Criteria 

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
No Results Posted