Healthy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC, a Recombinant Variant of Human Activated Protein C (APC), in Healthy Adult Volunteers
The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.
This is a single-center, sequential-cohort, double-blind, placebo-controlled, single- and
multiple-ascending dose study. Eligible adult subjects will be assigned sequentially to 1 of
10 cohorts, at successively higher single doses, followed by successively higher multiple
doses.
Single IV Doses: 5 subjects per cohort, aged 18-55, will be randomized in a 4:1 manner to
receive active drug (6, 30, 90, 180, 360, and TBD µg/kg) or to receive matching placebo
(Cohorts 1-6).
Multiple IV Doses: 8 subjects per cohort, aged 18-55, will be randomized in a 3:1 manner to
receive active drug (90, 180, 360, and TBD µg/kg) or to receive matching placebo every 12
hours for 5 doses (Cohorts 7-10).
Single-Dose Cohorts Subjects receiving a single dose will be confined in a Phase 1 unit for
12 hours prior to dosing, during dosing, and for 24 hours after dosing (Study Day 1-2) for
observation and PK sampling. Subjects will return on Study Day 4 (~72 hours after infusion)
and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be
made to subjects to collect AEs that occur within 28-days of the dose.
Multiple-Dose Cohorts Subjects receiving multiple doses will be confined in a Phase 1 unit
for 12 hours prior to dosing through 24 hours following the last dose (Study Day 1-4) for
observation and PK sampling. Subjects will return on Study Day 6 (~72 hours after last
infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call
will be made to subjects to collect AEs that occur within 28-days of the last dose.
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