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Study to Evaluate the AIO-001 in Healthy Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06170827•Syneos Health

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (1)

Q-Pharm Pty Ltd

Herston, Queensland, Australia

Key Dates

Start Date

November 21, 2023

Primary Completion Date

July 15, 2024

Completion Date

July 15, 2024

Last Updated

August 14, 2025

Enrollment

ACTUAL participants

Conditions

Respiratory Disease

Interventions

AIO-001

DRUG

A New Portable Device for Non-invasive Ventilatory Support

NCT06716502

HealthyRespiratory Disease

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RECRUITING

Procedural Skills Transfer in Bronchoscopy

NCT07168408

Respiratory Disease

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RECRUITINGNA

How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate the AIO-001 in Healthy Participants

Inclusion Criteria

Exclusion Criteria

A New Portable Device for Non-invasive Ventilatory Support

Procedural Skills Transfer in Bronchoscopy

How OMT Benefits Newly Diagnosed Patients With Respiratory Illness When Given Alongside Other Standard Care.

Prospective Observational Study to Characterize Patients Treated at Internal Medicine Clinics

Long-term Alterations of Host-microbiome Interactions and Cardiovascular and Respiratory Diseases Progression After Pneumonia

Extremely Preterm Respiratory Outcome Cohort