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

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Biological: IBIO123; Other: Placebo

• Registration Number: NCT05298813
• Lead Sponsor: Immune Biosolutions Inc

Brief Summary

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

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).

Study Timeline

• Study Start: 2021-09-29
• Study First Submitted: 2022-03-23
• Study First Submitted QC: 2022-03-24
• Study First Posted: 2022-03-28
• Primary Completion: 2023-01-04
• Study Completion: 2023-01-04
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

Age

1. Are ≥18 years of age at the time of randomization

   Disease Characteristics

2. Are currently not hospitalized

3. 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

4. Must have sample collection for first positive SARS-CoV-2 viral infection determination

   ≤3 days prior to start of the inhalation.

   Sex

5. 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

6. Understand and agree to comply with planned study procedures

7. Agree to the collection of nasopharyngeal swabs and venous blood Informed Consent

8. 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 9. Have SpO2 ≤ 93% on room air, respiratory rate ≥30 per minute, resting heart rate ≥125 per minute. 10. Require mechanical ventilation or anticipated impending need for mechanical ventilation 11. Have known allergies to any of the components used in the formulation of the interventions. 12. Have hemodynamic instability requiring use of pressors within 24 hours of randomization. 13. 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. 14. Have any co-morbidity requiring surgery or that is considered life- threatening within 29 days prior to dosing. 15. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study.

Other Exclusions

16. Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study. 17. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing. 18. Have received treatment with a SARS-CoV-2 specific monoclonal antibody. 19. 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. 20. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. 21. Are pregnant or breast feeding. 22. Are investigator site personnel directly affiliated with this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	IBIO123	-
Placebo	Placebo	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Characterize the effect of IBIO123 compared to placebo on overall participant clinical status	From Baseline to Day 29	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
Characterize the effect of IBIO123 compared to placebo on Baseline SARS-CoV-2 related symptoms	From Baseline to Day 29	• Time to symptom reduction or resolution and proportion of patients
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance	From Baseline to Day 29	• Proportion of participants who achieve SARS-CoV-2 clearance
Characterize the pharmacokinetics of IBIO123	Days 1, 3, 7, and 29	IBIO123 mean plasma concentration
Phase 1: Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load and viral clearance	From Baseline to Day 7	Change from baseline to Day 7 in SARS-CoV-2 viral load
Phase 2 : Characterize the effect of IBIO123 compared to placebo on safety and tolerability	From Baseline to Day 29	Safety assessments such as AEs and SAEs
Characterize the effect of IBIO123 compared to placebo on SARS-CoV-2 viral load among participants with ≤8 days since symptom onset	From Baseline to Day 7	Change from baseline to Day 7 in SARS-CoV-2 viral load among participants enrolled with ≤ 8 days of symptoms prior to randomization

Trial Locations

Locations (11)

Santa Casa de Misercórdia de Passos; 🇧🇷 Passos, Minas Gerais, Brazil

Durban International Clinical Research, Enhancing Care Foundation; 🇿🇦 Durban, Kwazulu-Natal, South Africa

Instituto Brasil de Pesquisa Clinica; 🇧🇷 Gloria, Rio De Janeiro, Brazil

Clinica Supera Oncologia; 🇧🇷 Chapecó, Santa Catarina, Brazil

FARMOVS; 🇿🇦 Bloemfontein, Free State, South Africa

Pesquisare Saúde; 🇧🇷 Santo André, Sao Paulo, Brazil

Newton Clinical Trial Centre; 🇿🇦 Newtown, Gauteng, South Africa

Jongaie Research; 🇿🇦 Pretoria West, Gauteng, South Africa

Johese Clinical Research ZAH; 🇿🇦 Pretoria, Gauteng, South Africa

Clinical Research Institute of South Africa - CRISA; 🇿🇦 Stanger, Kwazulu-Natal, South Africa

Instituto Brasileiro de Controle do Câncer / Sao Camilo Oncologia; 🇧🇷 Pompeia, Sao Paulo, Brazil