Clinical Trial: Phase 1, Randomized, Double-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of an Enterovirus D68-specific Monoclonal Antibody in Healthy Adults
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Enterovirus Infection
Study Type: INTERVENTIONAL
Official Title: A Phase 1, Placebo-Controlled, Double-Blinded Study to Assess the Safety and Pharmacokinetics of Single Ascending Doses of EV68-228-N Ins Healthy Adult Volunteers
Brief Summary:
This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single IV administrations of EV68-228-N in healthy adult volunteers.Three doses (3, 10 and 30 mg/kg) of EV68-228-N will be evaluated in three separate, sequential cohorts in this single dose escalation study.The cohorts will be randomized in a 5:1 randomization scheme.The first two participants in each cohort will serve as sentinels.Sentinel participants may be located at different…
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