First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.
This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects. 64 healthy male and female subjects are selected according to the inclusion and exclusion criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 \[Cohort A\], 28 \[Cohort B\], respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months. All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A staggered approach is observed within all dose levels. An interval of at least 14 days (last to first administration) is observed between all dose levels. Individual subjects on a same day of dosing are dosed at least 60 minutes apart.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
GMP FR104 is provided to the site in extractable volume vials containing FR104. Appropriate Dilutions in Ringer's lactate solution is made on site.
The placebo injection contains the vehicle. For placebo dosing, vehicle is administered in accordance with the volume of study drug administered.
SGS Antwerpen
Antwerp, Belgium
Type, incidence, severity, timing, seriousness and relatedness of treatment emergent adverse events, and abnormalities in laboratory parameters in healthy volunteers of FR104 compared to placebo after single (SAD) and two IV doses (MAD).
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Time frame: 4 months
Area under the concentration time curve to last quantifiable concentration [AUC (0-T)] after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Time frame: 4 months
Terminal half-life (T1/2) of FR104 after single and two repeat iv administrations
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Time frame: 4 months
Durations of 100%, 50% and 20% CD28 receptor blocade after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Time frame: 4 months
Incidence of antidrug antibodies (ADA) and neutralizing antibodies (NAb) after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
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Time frame: 4 months
Type, incidence, severity, timing, seriousness and relatedness of abnormal cytokine levels after single and two repeat iv administrations of FR104
During each treatment period, subjects will be housed and monitored at the study center from the day before dosing (Day-1) until Day 5. Thenafter, each subject will attend ambulatory visit at predefined days until day 113.
Time frame: 4 months