Study to Evaluate the AIO-001 in Healthy Participants

Syneos Health

Status and phase: Completed; Phase 1

Conditions: Respiratory Disease

Treatments: Drug: AIO-001

Study type: Interventional

Funder types: Other

Identifiers

NCT06170827

AIO-001-101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

AIO-001 (Formulation A)

Experimental group

Description:

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

Treatment:

Drug: AIO-001

AIO-001 (Formulation B)

Experimental group

Description:

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

Treatment:

Drug: AIO-001