Clinical trial NCT06170827: Study to Evaluate the AIO-001 in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Respiratory Disease
Lead sponsor: Syneos Health
Sponsor class: OTHER
Collaborators: name: Aiolos Bio, Inc., a GSK Company
First posted: 2023-12-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants with Adverse events (AEs)
timeFrame: From start of study drug administration up to 24 weeks
measure: Number of Participants with Clinically Significant Changes in Vital Signs
timeFrame: From start of study drug administration up to 24 weeks
measure: Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram Parameters
timeFrame: From start of study drug administration up to 24 weeks
measure: Number of Participants with Clinically Significant Changes in Physical Examination Findings
timeFrame: From start of study drug administration up to 24 weeks
measure: Number of Participants with Clinically Significant Changes in Clinical laboratory Parameters
timeFrame: From start of study drug administration up to 24 weeks
Secondary outcomes:
measure: Pharmacokinetic (PK): Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001
timeFrame: Pre-dose up to 4056 hours post-dose
measure: PK: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) of AIO-001
timeFrame: Pre-dose up to 4032 hours post-dose
measure: PK: Maximal Observed Concentration (Cmax) of AIO-001
timeFrame: Pre-dose up to 4032 hours post-dose
measure: PK: Time to Maximal Concentration Observed (Tmax) of AIO-001
timeFrame: Pre-dose up to 4032 hours post-dose
measure: PK: Terminal Elimination Half-life (T½) of AIO-001
timeFrame: Pre-dose up to 4032 hours post-dose
measure: Number of Participants with Anti-drug Antibody (ADA) to AIO-001
timeFrame: From Day 1 up to Day 169
Other outcomes:
Locations:
city: Herston
country: Australia
facility: Q-Pharm Pty Ltd
state: Queensland
Study officials:
affiliation: Nucleus Network
name: Gloria Wong
role: PRINCIPAL_INVESTIGATOR
References: