A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Study Overview
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Brief Summary
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This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.

Official Title
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A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Conditions
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Asthma

Intervention / Treatment
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* Drug: AIR645
* Drug: Physiologic saline solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria*: Good General Health (with or without allergic rhinitis and/or controlled asthma) Non-smoker for at least 2 years Normal lung function (DLCO) Able to provide informed consent and to understand and comply with the requirements of the study Exclusion Criteria*: Clinically significant medical history or condition which precludes participation Clinically significant ECG abnormality Clinically significant VS or PE abnormality Clinically significant screening lab abnormality Abnormal lung function (FEV1 <80% predicted) Respiratory infection within 14 days of randomization HBV, HCV, or HIV Breastfeeding or pregnant female History of alcohol abuse or illicit drug use within past 24 months Use of any tobacco or nicotine-containing product within past 6 months Use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol Use of any investigational drug within past 30 days Use of any investigational monoclonal antibody or recombinant protein within past 90 days Donation of plasma within past 7 days Donation or loss of whole blood within past 56 days Simplified list of I/E criteria; unabridged list available upon request.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) | Drug: AIR645<br>* AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.<br>|
| Placebo Comparator: 2<br>Physiologic saline solution | Drug: Physiologic saline solution<br>* Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of the safety and tolerability of AIR645 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, pulmonary function tests, heart rhythm, and laboratory tests. |  | During dosing and for two weeks after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability |  | During dosing and for two weeks after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIR645, Altair Therapeutics, IL4, IL13, IL-4, IL-13