Study to Evaluate the AIO-001 in Healthy Participants

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Disease
• Intervention / Treatment: Drug: AIO-001

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Reza Pishva; Phone Number: 61(0)410 308 134; Email: reza.pishva@syneoshealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Able to understand the study procedures and provide signed informed consent to participate in the study.
2. Male or female.
3. 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.
4. ≥18 and ≤55 years of age.
5. BMI >18.5 and <32.0 kg/m2 and body weight ≥45.0 kg.
6. Healthy participants.

Exclusion Criteria:

1. Any clinically significant abnormal finding at physical examination at screening.
2. 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.
3. Positive pregnancy test or lactating female participant.
4. Positive urine drug screen or alcohol breath test.
5. History of anaphylaxis, or severe allergy.
6. Previous exposure to thymic stromal lymphopoietin antibody.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Syneos Health
• Collaborators: Aiolos Bio, Inc.
• Investigators: Principal Investigator: Gloria Wong, Nucleus Network

Study record dates

Study Major Dates

• Study Start (Estimated): December 19, 2023
• Primary Completion (Estimated): December 20, 2024
• Study Completion (Estimated): December 20, 2024

Study Registration Dates

• First Submitted: November 26, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: AIO-001-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No