Study to Evaluate the AIO-001 in Healthy Participants

• Status: Active, not recruiting
• Trial end date: 2024-12-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Syneos Health
• Collaborator: Aiolos Bio, Inc.

Criteria

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.