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Completed

NCT Number: NCT06170827

Study to Evaluate the AIO-001 in Healthy Participants

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.

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Key information

Conditions

Respiratory Disease Respiration Disorders Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Q-Pharm Pty Ltd

Herston, Queensland, 4006, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AIO-001

Drug

AIO-001 Solution for SC injection.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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

    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.

  2. 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

    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.

  3. 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

    Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.

  4. 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

    Blood samples were collected at indicated time points for PK analysis of AIO-001. PK analysis was conducted using standard non-compartmental methods.

  5. 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

    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.

  6. Number of Participants With Positive Anti-drug Antibody (ADA) to AIO-001

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Syneos Health

Other

Collaborators

  • Aiolos Bio, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 14, 2023
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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