NCT06170827

Study to Evaluate the AIO-001 in Healthy Participants

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Syneos Health · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiratory Disease

Interventions

Type	Name	Description
DRUG	AIO-001	AIO-001 Solution for SC injection.

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-07-15
• Completion: 2024-07-15
• First posted: 2023-12-14
• Last updated: 2025-08-14
• Results posted: 2025-08-14

Locations

1 site across 1 country: Australia