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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06170827




Registration number
NCT06170827
Ethics application status
Date submitted
26/11/2023
Date registered
14/12/2023
Date last updated
23/05/2024

Titles & IDs
Public title
Study to Evaluate the AIO-001 in Healthy Participants
Scientific title
Open-Label, Single Dose, Parallel Group, Phase 1 Study in Healthy Volunteers Evaluating Safety, Tolerability, Pharmacokinetics, and Immunogenicity AIO-001 Administered by Injections
Secondary ID [1] 0 0
AIO-001-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AIO-001

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

Experimental: AIO-001 (Formulation B) - 400 mg of 182 mg/ml AIO-001 SC injection will be administered.


Treatment: Drugs: AIO-001
AIO-001 Solution for SC injection.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse events (AEs)
Timepoint [1] 0 0
From start of study drug administration up to 24 weeks
Primary outcome [2] 0 0
Number of Participants with Clinically Significant Changes in Vital Signs
Timepoint [2] 0 0
From start of study drug administration up to 24 weeks
Primary outcome [3] 0 0
Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram Parameters
Timepoint [3] 0 0
From start of study drug administration up to 24 weeks
Primary outcome [4] 0 0
Number of Participants with Clinically Significant Changes in Physical Examination Findings
Timepoint [4] 0 0
From start of study drug administration up to 24 weeks
Primary outcome [5] 0 0
Number of Participants with Clinically Significant Changes in Clinical laboratory Parameters
Timepoint [5] 0 0
From start of study drug administration up to 24 weeks
Secondary outcome [1] 0 0
Pharmacokinetic (PK): Area Under the Concentration-time Curve from Time Zero Until the Last Observed Concentration (AUC0-last) of AIO-001
Timepoint [1] 0 0
Pre-dose up to 4056 hours post-dose
Secondary outcome [2] 0 0
PK: Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) of AIO-001
Timepoint [2] 0 0
Pre-dose up to 4032 hours post-dose
Secondary outcome [3] 0 0
PK: Maximal Observed Concentration (Cmax) of AIO-001
Timepoint [3] 0 0
Pre-dose up to 4032 hours post-dose
Secondary outcome [4] 0 0
PK: Time to Maximal Concentration Observed (Tmax) of AIO-001
Timepoint [4] 0 0
Pre-dose up to 4032 hours post-dose
Secondary outcome [5] 0 0
PK: Terminal Elimination Half-life (T½) of AIO-001
Timepoint [5] 0 0
Pre-dose up to 4032 hours post-dose
Secondary outcome [6] 0 0
Number of Participants with Anti-drug Antibody (ADA) to AIO-001
Timepoint [6] 0 0
From Day 1 up to Day 169

Eligibility
Key inclusion criteria
1. Able to understand the study procedures and provide signed informed consent to
participate in the study.

2. Male or female.

3. 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.

4. =18 and =55 years of age.

5. BMI >18.5 and <32.0 kg/m2 and body weight =45.0 kg.

6. Healthy participants.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any clinically significant abnormal finding at physical examination at screening.

2. 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.

3. Positive pregnancy test or lactating female participant.

4. Positive urine drug screen or alcohol breath test.

5. History of anaphylaxis, or severe allergy.

6. Previous exposure to thymic stromal lymphopoietin antibody.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
20/12/2024
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Aiolos Bio, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06170827
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gloria Wong
Address 0 0
Nucleus Network
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries