PMC

This flow diagram depicts the disposition of the participants in this single-dose, dose-escalation study of intravenously administered VX15/2503. Forty participants were treated with VX15/2503 and 10 with placebo; none discontinued the study. The median infusion time for all patients was 60 minutes, with durations ranging from 45 to 170 minutes.

Percent VX15/2503 saturation of cSEMA4D on peripheral T lymphocytes is shown for antibody-treated participants in each dose cohort. The scheduled sampling times for each dose cohort were as described in the legend of . Data shown represent mean values ± SE; flow cytometric assays were performed in triplicate and data analyzed as previously described.^, T-cell saturation values below 20% were considered unsaturated; mean predose saturation values ranged between 0.7% and 18%.

Mean serum VX15/2503 concentrations are shown vs scheduled sampling days. Data shown are for antibody-treated patients in each of the 5 dose cohorts; samples from placebo-treated subjects were assayed but not reported because of the absence of antibody in these samples. Sampling times were end of infusion, 4 and 8 hours on days 1 2, 4, 8, 15, 29, 43, 57, 71, 85, 155, and 190; time points beyond day 29 were successively applied to cohorts 2 through 5. Data shown represent mean values ± SD. Serum assays were performed in triplicate using a validated method.^,