Study to Evaluate the AIO-001 in Healthy Participants

NCT06170827 | Completed Phase 1 Results

• 1 other identifier: AIO-001-101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Disease

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  Pre-dose, 12, 24, 48, 72, 96, 120, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016, 2688, 3360, and 4056 hours post-dose

Study Arms (2)

AIO-001 (Formulation A)

EXPERIMENTAL

400 milligram (mg) of 100 milligrams per milliliter (mg/ml) AIO-001 Subcutaneous (SC) injection will be administered.

Drug: AIO-001

AIO-001 (Formulation B)

EXPERIMENTAL

400 mg of 182 mg/ml AIO-001 SC injection will be administered.

Drug: AIO-001

Interventions

AIO-001 DRUG

AIO-001 Solution for SC injection.

AIO-001 (Formulation A); AIO-001 (Formulation B)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Syneos Health: lead
• Aiolos Bio, Inc., a GSK Company: collaborator

Study Sites (1)

Q-Pharm Pty Ltd

Herston, Queensland, 4006, Australia

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@GSK.com

866-435-7343

Study Officials

• Principal Investigator

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 14, 2023
• Study Start: November 21, 2023
• Primary Completion: July 15, 2024
• Study Completion: July 15, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

AU (1)