A COVID-19 Study to Evaluate Safety and Pharmacokinetics of COVID-HIGIV Administered in Healthy Adults

Summary

Participation Requirements

Description

This study will be a Phase 1, single-center, randomized, double-blind, placebo-controlled design to assess safety and PK of COVID-HIGIV in healthy adults. In total, 56 healthy adult subjects are planned to be enrolled and randomized into two cohorts of healthy adult subjects; 28 subjects in cohort A...

This study will be a Phase 1, single-center, randomized, double-blind, placebo-controlled design to assess safety and PK of COVID-HIGIV in healthy adults. In total, 56 healthy adult subjects are planned to be enrolled and randomized into two cohorts of healthy adult subjects; 28 subjects in cohort A and 28 subjects in cohort B. The enrollment/randomization of study subjects will be first initiated for cohort A. Once all subjects from cohort A complete Day 29 visit, an interim analysis will be performed to assess initial safety and PK of a single IV infusion of three dose levels of COVID-HIGIV in healthy adults. Eligible subjects for cohort A will be randomized 2:2:2:1 to four study treatment arms to receive a single IV infusion of one of three COVID-HIGIV dose levels or saline placebo, respectively. Eligible subjects for cohort B will be randomized 2:2:2:1 to four study treatment arms to receive two IV doses (28 days apart) of one of three COVID-HIGIV dose levels or saline placebo, respectively. Enrollment of subjects for cohort B will be initiated following cohort A interim Day 29 analysis. The enrollment/dosing of the first seven subjects in the study (from cohort A) will be staggered. Available safety data will be reviewed by Study Monitoring Committee (SMC) after seven subjects from cohort A have completed at least 72 hours of safety follow-up. Subjects in cohort A will be followed up for safety and PK up to 84 days post-administration of a single dose, while subjects in cohort B will be followed up for safety and PK up to 28 days post-administration of the initial dose and up to 56 days post-administration of the repeat dose. The SMC will perform overall ongoing review of safety data during the study.

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