Phase 1/2 Study to Evaluate the Efficacy and Safety of Inhaled IBIO123 in Participants With Mild to Moderate COVID-19 Illness

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Biological: IBIO123
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age Are ≥18 years of age at the time of randomization Disease Characteristics Are currently not hospitalized Have one or more mild or moderate COVID-19 symptoms: i. Fever ii. Cough iii. Sore throat iv. Malaise v. Headache vi. Muscle pain vii. Gastrointestinal symptoms, or viii. Shortness of breath with exertion Must have sample collection for first positive SARS-CoV-2 viral infection determination ≤3 days prior to start of the inhalation. Sex Are men or non-pregnant women Reproductive and Contraceptive agreements and guidance is provided in Section 10.4, Appendix 4. Contraceptive use by men or women should be consistent with local regulations for those participating in clinical studies. Study Procedures Understand and agree to comply with planned study procedures Agree to the collection of nasopharyngeal swabs and venous blood Informed Consent The participant or legally authorized representative gives signed informed consent as described in Section 14.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Medical Conditions Have SpO2 ≤ 93% on room air, respiratory rate ≥30 per minute, resting heart rate ≥125 per minute. Require mechanical ventilation or anticipated impending need for mechanical ventilation Have known allergies to any of the components used in the formulation of the interventions. Have hemodynamic instability requiring use of pressors within 24 hours of randomization. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention. Have any co-morbidity requiring surgery or that is considered life- threatening within 29 days prior to dosing. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study. Other Exclusions Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing. Have received treatment with a SARS-CoV-2 specific monoclonal antibody. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Are pregnant or breast feeding. Are investigator site personnel directly affiliated with this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Biological: IBIO123<br>* IBIO123 1 mg, 5 mg and 10 mg<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase 1 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability | Safety assessments such as AEs and SAEs | From Baseline to Day 29 | 
| Phase 2: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance | Change from baseline to Day 7 in SARS-CoV-2 viral load | From Baseline to Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the effect of IBIO123 compared to placebo on overall participant clinical status | Proportion (percentage) of participants who experience these events by Day 29: COVID-19 related hospitalization (defined as ≥24 hours of acute care) a COVID-19 related emergency room visit, or death | From Baseline to Day 29 | 
| Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load among participants with ≤8 days since symptom onset | Change from baseline to Day 7 in SARS-CoV-2 viral load among participants enrolled with ≤ 8 days of symptoms prior to randomization | From Baseline to Day 7 | 
| Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms | • Time to symptom reduction or resolution and proportion of patients | From Baseline to Day 29 | 
| Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance | • Proportion of participants who achieve SARS-CoV-2 clearance | From Baseline to Day 29 | 
| Characterize the pharmacokinetics of IBIO123 | IBIO123 mean plasma concentration | Days 1, 3, 7, and 29 | 
| Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance | Change from baseline to Day 7 in SARS-CoV-2 viral load | From Baseline to Day 7 | 
| Phase 2 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability | Safety assessments such as AEs and SAEs | From Baseline to Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBIO, IBIO123, mild COVID-19, moderate COVID-19, monoclonal antibodies, inhalation