Study to Evaluate the AIO-001 in Healthy Participants

Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06170827
• Other study ID #: AIO-001-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 1, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: December 2023
• Source: Syneos Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Respiration Disorders
• Respiratory Disease
• Respiratory Tract Diseases

Intervention

Drug:
• AIO-001
AIO-001 Solution for SC injection.

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Herston	Queensland

Sponsors (2)

Lead Sponsor	Collaborator
Syneos Health	Aiolos Bio, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse events (AEs)		From start of study drug administration up to 24 weeks
Primary	Number of Participants with Clinically Significant Changes in Vital Signs		From start of study drug administration up to 24 weeks
Primary	Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram Parameters		From start of study drug administration up to 24 weeks
Primary	Number of Participants with Clinically Significant Changes in Physical Examination Findings		From start of study drug administration up to 24 weeks
Primary	Number of Participants with Clinically Significant Changes in Clinical laboratory Parameters		From start of study drug administration up to 24 weeks
Secondary	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
Secondary	PK: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) of AIO-001		Pre-dose up to 4032 hours post-dose
Secondary	PK: Maximal Observed Concentration (Cmax) of AIO-001		Pre-dose up to 4032 hours post-dose
Secondary	PK: Time to Maximal Concentration Observed (Tmax) of AIO-001		Pre-dose up to 4032 hours post-dose
Secondary	PK: Terminal Elimination Half-life (T½) of AIO-001		Pre-dose up to 4032 hours post-dose
Secondary	Number of Participants with Anti-drug Antibody (ADA) to AIO-001		From Day 1 up to Day 169