Phase 1
Completed N=16
Study to Evaluate the AIO-001 in Healthy Participants
Respiratory Disease
Source: ClinicalTrials.gov NCT06170827 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) — 5; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
5; 6 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Physical Examination Findings |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters |
0; 0 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001 |
4608.31; 4935.31 | — |
| SECONDARY Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001 |
7092.12; 8088.05 | — |
| SECONDARY Maximal Observed Concentration (Cmax) of AIO-001 |
43.69; 47.49 | — |
| SECONDARY Time to Maximal Observed Concentration (Tmax) of AIO-001 |
13.55; 17.43 | — |
| SECONDARY Terminal Elimination Half-life (T½) of AIO-001 |
104.34; 119.35 | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001 |
0; 4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06170827). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.