Study to Evaluate the AIO-001 in Healthy Participants

Study Overview
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Brief Summary
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This goal of the open-label single dose study is to evaluate and compare the safety, tolerability, pharmacokinetic (PK), and immunogenicity of AIO-001 using two different formulations in 16 healthy volunteers.

Detailed Description
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This is an open-label single dose, parallel group, 24-week, Phase 1 study in 16 healthy participants. The study is designed to evaluate and compare the safety, tolerability, PK, and immunogenicity of AIO-001 using two different formulations (Formulation A and Formulation B) in 16 healthy volunteers (8 receiving each formulation). The study will include a screening visit from Day -28 to Day -2. Eligible participants will be admitted to the clinical site on Day -1 and will be confined until completion of the assessments on Day 3. Participants will return to the clinical site for outpatient visits for study assessments and laboratory tests.

Official Title
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Open-Label, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity AIO-001 Administered by Injections

Conditions
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Respiratory Disease

Intervention / Treatment
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* Drug: AIO-001


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand the study procedures and provide signed informed consent to participate in the study. Male or female. Non-smokers. Light smokers (no more than 5 cigarettes daily [approximately 50 to 60 mg of nicotine per day], or products with equivalent amount of nicotine within 3 months prior to screening) may be permitted. ≥18 and ≤55 years of age. BMI >18.5 and <32.0 kg/m2 and body weight ≥45.0 kg. Healthy participants. Exclusion Criteria: Any clinically significant abnormal finding at physical examination at screening. Clinically significant abnormal laboratory test results or positive serology test results for hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen and antibody, or QuantiFERON®-TB tuberculosis (TB) test at screening. Positive pregnancy test or lactating female participant. Positive urine drug screen or alcohol breath test. History of anaphylaxis, or severe allergy. Previous exposure to thymic stromal lymphopoietin antibody.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AIO-001 (Formulation A)<br>400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered. | Drug: AIO-001<br>* AIO-001 Solution for SC injection.<br>|
| Experimental: AIO-001 (Formulation B)<br>400 mg of 182 mg/ml AIO-001 SC injection will be administered. | Drug: AIO-001<br>* AIO-001 Solution for SC injection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse events (AEs) |  | From start of study drug administration up to 24 weeks | 
| Number of Participants with Clinically Significant Changes in Vital Signs |  | From start of study drug administration up to 24 weeks | 
| Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram Parameters |  | From start of study drug administration up to 24 weeks | 
| Number of Participants with Clinically Significant Changes in Physical Examination Findings |  | From start of study drug administration up to 24 weeks | 
| Number of Participants with Clinically Significant Changes in Clinical laboratory Parameters |  | From start of study drug administration up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK): Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001 |  | Pre-dose up to 4056 hours post-dose | 
| PK: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) of AIO-001 |  | Pre-dose up to 4056 hours post-dose | 
| PK: Maximal Observed Concentration (Cmax) of AIO-001 |  | Pre-dose up to 4056 hours post-dose | 
| PK: Time to Maximal Concentration Observed (Tmax) of AIO-001 |  | Pre-dose up to 4056 hours post-dose | 
| PK: Terminal Elimination Half-life (T½) of AIO-001 |  | Pre-dose up to 4056 hours post-dose | 
| Number of Participants with Anti-drug Antibody (ADA) to AIO-001 |  | From Day 1 up to Day 169 |