Adults 18 to 55, any sex, with Respiratory Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· From Day 1 up to Day 169
An AE was defined as any untoward medical occurrence in a participant or clinical trial participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE can, therefore, be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. TEAEs were defined as AEs that commence on or after the time of study drug administration.
Group
Value
95% CI
AIO-001: Formulation A
5
AIO-001: Formulation B
6
Number of Participants With Clinically Significant Changes in Vital SignsPrimary· Baseline (Day -1) up to Day 169
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement.
Group
Value
95% CI
AIO-001: Formulation A
0
AIO-001: Formulation B
0
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram ParametersPrimary· Baseline (Day -1) up to Day 169
The electrocardiogram parameters included heart rate, PR interval, QT interval, corrected QT (QTcF using Fridericia's formula) interval and QRS. The clinically significant changes were based on investigator's judgement.
Group
Value
95% CI
AIO-001: Formulation A
0
AIO-001: Formulation B
0
Number of Participants With Clinically Significant Changes in Physical Examination FindingsPrimary· Baseline (Day -1) up to Day 169
Physical examination included assessments of the following: head, eyes, ears, nose, throat, neck, chest, lungs, abdomen, musculoskeletal, dermatological, cardiovascular/peripheral vascular, and general neurological examination. The clinically significant changes were based on investigator's judgement.
Group
Value
95% CI
AIO-001: Formulation A
0
AIO-001: Formulation B
0
Number of Participants With Clinically Significant Changes in Clinical Laboratory ParametersPrimary· Baseline (Day -1) up to Day 169
Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement.
Group
Value
95% CI
AIO-001: Formulation A
0
AIO-001: Formulation B
0
Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001Secondary· Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Group
Value
95% CI
AIO-001: Formulation A
4608.31
± 30.04
AIO-001: Formulation B
4935.31
± 18.18
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001Secondary· Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of AUC0-inf may be non-identifiable.
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods. The residual area was greater than 20% in 15 out of the total of 16 participants and therefore the estimation of T½ may be non-identifiable.
Group
Value
95% CI
AIO-001: Formulation A
104.34
± 24.11
AIO-001: Formulation B
119.35
± 45.20
Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001Secondary· Up to Day 169
ADA-positive participant was defined as participant with at least one treatment-induced or treatment-boosted ADA-positive sample at any time during the treatment or follow-up observation period. Anti-AIO-001 antibodies were evaluated in serum samples. Serum samples were screened for antibodies binding to AIO-001.
Group
Value
95% CI
AIO-001: Formulation A
0
AIO-001: Formulation B
4
Adverse events — posted to ClinicalTrials.gov
Time frame: All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from start of study drug administration (Day 1) up to Day 169.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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· NA
· active not recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Syneos Health
Last refreshed: 14 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06170827.