COVID-19 Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-Controlled, Escalating Single Dose, Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness
This is a Phase 1/2, randomized, double-blind, placebo-controlled, single-dose escalating-dose study in participants with mild to moderate COVID-19 illness.
Participants will be randomized to placebo or IBIO123. In the phase 1 portion of the study, a total of 24 patients will be enrolled in 3 cohorts of 8 patients each. Six (6) of the 8 patients in each cohort will receive IBIO123 and 2 patients will receive placebo. The first cohort will be dosed with 1 mg. Subsequent cohorts will receive 5 mg, and 10 mg of IBIO123 or matching placebo and will be dosed at least 1 week apart to allow for review of safety and tolerability data for each prior cohort. In the phase 2 portion of the study, as dose levels in phase 1 are determined to be safe, these dose levels may be introduced in phase 2 of Study IBIO-INH-001. This table describes the planned treatment arms. The Phase 2 portion of the study will enroll a total of approximately 200 participants (150 participants on study drug & 50 participants on Placebo). ;
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