A Phase 1 interventional study of AIO-001 in Respiratory Disease, sponsored by Syneos Health. Completed at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Syneos Health · Phase 1, Interventional, and Treatment
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.
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.
513 studies on the registry are indexed under Respiration Disorders; 98 are open to participants now.
This study's enrollment of 16 is below the median of 64 across 290 interventional studies indexed under Respiration Disorders.
Browse Respiration Disorders studies →Syneos Health is the lead sponsor of 22 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered.
Drug: AIO-001
400 mg of 182 mg/ml AIO-001 SC injection will be administered.
Drug: AIO-001
AIO-001 Solution for SC injection.
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: From Day 1 up to Day 169
Number of Participants With Clinically Significant Changes in Vital Signs
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement.
Time frame: Baseline (Day -1) up to Day 169
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters
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.
Time frame: Baseline (Day -1) up to Day 169
Number of Participants With Clinically Significant Changes in Physical Examination Findings
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.
Time frame: Baseline (Day -1) up to Day 169
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement.
Time frame: Baseline (Day -1) up to Day 169
Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001
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.
Time frame: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Maximal Observed Concentration (Cmax) of AIO-001
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Time to Maximal Observed Concentration (Tmax) of AIO-001
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
Time frame: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Terminal Elimination Half-life (T½) of AIO-001
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.
Time frame: Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose
Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001
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.
Time frame: Up to Day 169
| Milestone | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Started | 8 | 8 |
| Completed | 7 | 7 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
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.
| Participants | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | 5 | 6 |
Vital sign measurements included blood pressure, heart rate, respiratory rate, and oral temperature measurements. The clinically significant changes were based on investigator's judgement.
| Participants | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Vital Signs | 0 | 0 |
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.
| Participants | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters | 0 | 0 |
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.
| Participants | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Physical Examination Findings | 0 | 0 |
Clinical laboratory parameters included biochemistry, hematology, and urinalysis assessment. The clinically significant changes were based on investigator's judgement.
| Participants | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters | 0 | 0 |
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
| day*microgram per milliliter(day*mcg/mL) | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001 | 4608.31 ± 30.04 | 4935.31 ± 18.18 |
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.
| day*mcg/mL | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of AIO-001 | 7092.12 ± 30.49 | 8088.05 ± 22.92 |
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
| micrograms per milliliter (mcg/mL) | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Maximal Observed Concentration (Cmax) of AIO-001 | 43.69 ± 35.83 | 47.49 ± 22.22 |
Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.
| day | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Time to Maximal Observed Concentration (Tmax) of AIO-001 | 13.55 (7.94 to 21.97) | 17.43 (4.00 to 27.16) |
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.
| day | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Terminal Elimination Half-life (T½) of AIO-001 | 104.34 ± 24.11 | 119.35 ± 45.20 |
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.
| Participants | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001 | 0 | 4 |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AIO-001: Formulation A | 0/8 (0%) | 0/8 (0%) | 5/8 (62.5%) |
| AIO-001: Formulation B | 0/8 (0%) | 0/8 (0%) | 6/8 (75%) |
| Event | AIO-001: Formulation A | AIO-001: Formulation B |
|---|---|---|
| HeadacheNervous system disorders | 1/8 | 2/8 |
| COVID-19Infections and infestations | 1/8 | 1/8 |
| PneumoniaInfections and infestations | 0/8 | 1/8 |
| TonsillitisInfections and infestations | 0/8 | 1/8 |
| Tooth infectionInfections and infestations | 0/8 | 1/8 |
| Upper respiratory tract infectionInfections and infestations | 1/8 | 0/8 |
| Viral upper respiratory tract infectionInfections and infestations | 0/8 | 1/8 |
| Wound infectionInfections and infestations | 1/8 | 0/8 |
| HypoaesthesiaNervous system disorders | 0/8 | 1/8 |
| ParaesthesiaNervous system disorders | 0/8 | 1/8 |
| Age, Continuous(years) | AIO-001: Formulation A | AIO-001: Formulation B | Total |
|---|---|---|---|
| Mean | 33.5 ± 7.45 | 32.8 ± 10.48 | 33.1 ± 8.79 |
| Sex: Female, Male(Participants) | AIO-001: Formulation A | AIO-001: Formulation B | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 1 | 2 | 3 |
| Ethnicity (NIH/OMB)(Participants) | AIO-001: Formulation A | AIO-001: Formulation B | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 7 | 7 | 14 |
| Unknown or Not Reported | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: Sharing Clinical Trial Data' on the GSK Study Register (www.gsk-studyregister.com).
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