Clinical trial

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

ID

Name

AIO-001-101

Description

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 arms

Trial start

2023-12-01

Estimated PCD

2024-12-20

Trial end

2024-12-20

Status

Active (not recruiting)

Phase

Early phase I

Treatment

AIO-001

AIO-001 Solution for SC injection.

Arms:

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

Size

16

Primary endpoint

Number of Participants with Adverse events (AEs)

From start of study drug administration up to 24 weeks

Number of Participants with Clinically Significant Changes in Vital Signs

From start of study drug administration up to 24 weeks

Number of Participants with Clinically Significant Changes in 12-lead Electrocardiogram Parameters

From start of study drug administration up to 24 weeks

Number of Participants with Clinically Significant Changes in Physical Examination Findings

From start of study drug administration up to 24 weeks

Number of Participants with Clinically Significant Changes in Clinical laboratory Parameters

From start of study drug administration up to 24 weeks

Eligibility criteria

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ESTIMATED'}}

Updated at

2024-05-23

1 organization

1 product

1 indication

Organization

Product

Indication

respiratory disease