Study to Evaluate the AIO-001 in Healthy Participants
- Registration Number
- NCT06170827
- Lead Sponsor
- Syneos Health
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AIO-001 (Formulation A) AIO-001 400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered. AIO-001 (Formulation B) AIO-001 400 mg of 182 mg/ml AIO-001 SC injection will be administered.
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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: Maximal Observed Concentration (Cmax) of AIO-001 Pre-dose up to 4032 hours post-dose PK: Time to Maximal Concentration Observed (Tmax) of AIO-001 Pre-dose up to 4032 hours post-dose PK: Terminal Elimination Half-life (T½) of AIO-001 Pre-dose up to 4032 hours post-dose Number of Participants with Anti-drug Antibody (ADA) to AIO-001 From Day 1 up to Day 169
Trial Locations
- Locations (1)
Q-Pharm Pty Ltd
🇦🇺Herston, Queensland, Australia