Status:
COMPLETED
Study to Evaluate the AIO-001 in Healthy Participants
Lead Sponsor:
Syneos Health
Collaborating Sponsors:
Aiolos Bio, Inc., a GSK Company
Conditions:
Respiratory Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 vo...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06170827
Start Date
November 21 2023
End Date
July 15 2024
Last Update
August 14 2025
Active Locations (1)
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1
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006