Respiratory DiseasePhase 1NCT06170827

Study to Evaluate the AIO-001 in Healthy Participants

A Phase 1 study testing AIO-001 in people with Respiratory Disease, run by Syneos Health at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Respiratory Disease
What is being tested?: AIO-001
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 1 siteAustralia
Study dates: 21 Nov 2023to 15 Jul 2024
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Australia1 site

Q-Pharm Pty Ltd
Herston, Queensland, 4006

Other trials in Australia

About this study

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

Read the 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
Being tested: AIO-001
Medical subject headings: Respiration Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AIO-001Drug
AIO-001 Solution for SC injection.

Study groups in NCT06170827
Study group	Role	What they receive
AIO-001 (Formulation A)	Experimental	400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered. Receives: Drug: AIO-001
AIO-001 (Formulation B)	Experimental	400 mg of 182 mg/ml AIO-001 SC injection will be administered. Receives: Drug: AIO-001

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day -1) up to Day 169

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to Day 169

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202315 Jul 2024

First posted14 Dec 2023
Study start21 Nov 2023
Primary completion15 Jul 2024
Study completion15 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06170827
Sponsor's protocol ID: AIO-001-101
Status last verified: Jul 2025
First submitted: 26 Nov 2023
Last updated: 14 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT06170827
Acronym / sponsor ID: AIO-001-101
Conditions: Respiratory Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 16 participants (actual)
Lead sponsor: Syneos HealthUniversity, hospital or other
Collaborators: Aiolos Bio, Inc.
Study start: 21 Nov 2023 (actual)
Primary completion: 15 Jul 2024 (actual)
Study completion: 15 Jul 2024 (actual)
First posted: 14 Dec 2023 (actual)
Results: Posted 14 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is an open-label single dose, parallel group, 24-week, Phase 1 study in 16 healthy participants.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AIO-001 (Formulation A)	Experimental	Drug: AIO-001400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered.
AIO-001 (Formulation B)	Experimental	Drug: AIO-001400 mg of 182 mg/ml AIO-001 SC injection will be administered.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AIO-001AIO-001 Solution for SC injection.	Drug	AIO-001 (Formulation A), AIO-001 (Formulation B)

Primary outcome

Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: 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.
Number of Participants With Clinically Significant Changes in Vital Signs
Time frame: 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.
Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters
Time frame: 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.
Number of Participants With Clinically Significant Changes in Physical Examination Findings
Time frame: 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.
Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters
Time frame: 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.

6 secondary outcomes

Area Under the Concentration-time Curve From Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001
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
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
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
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
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
Time frame: Up to Day 169

Results and safety

Results posted to the registry on 14 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AIO-001: Formulation A	8	7
AIO-001: Formulation B	8	7

Primary outcome: Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Time frame: From Day 1 up to Day 169. Count of participants. Unit: Participants

Measure	AIO-001: Formulation A n = 8	AIO-001: Formulation B n = 8
Value	5	6

Population analysed: The safety population included all participants who received at least one dose of the study drug.

Primary outcome: Number of Participants With Clinically Significant Changes in Vital Signs

Time frame: Baseline (Day -1) up to Day 169. Count of participants. Unit: Participants

Measure	AIO-001: Formulation A n = 8	AIO-001: Formulation B n = 8
Value	0	0

Population analysed: The safety population included all participants who received at least one dose of the study drug.

Primary outcome: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram Parameters

Time frame: Baseline (Day -1) up to Day 169. Count of participants. Unit: Participants

Measure	AIO-001: Formulation A n = 8	AIO-001: Formulation B n = 8
Value	0	0

Population analysed: The safety population included all participants who received at least one dose of the study drug.

Primary outcome: Number of Participants With Clinically Significant Changes in Physical Examination Findings

Time frame: Baseline (Day -1) up to Day 169. Count of participants. Unit: Participants

Measure	AIO-001: Formulation A n = 8	AIO-001: Formulation B n = 8
Value	0	0

Population analysed: The safety population included all participants who received at least one dose of the study drug.

6 secondary outcomes are reported in the full results.

Adverse events

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. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AIO-001: Formulation A	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
AIO-001: Formulation B	0 of 8 (0%)	6 of 8 (75%)	0 of 8

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Principal Investigator principal investigator

Nucleus Network

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AIO-001 in people with Respiratory Disease, run by Syneos Health at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-emergent Adverse Events (TEAEs) (time frame: From Day 1 up to Day 169). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06170827.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.