A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study Evaluating the Effects of AIR645 on Allergen-Induced Airway Responses in Subjects With Mild Atopic Asthma

NCT00941577

Asthma

COMPLETED PHASE2

Asthma Intervention Research (AIR) Trial

NCT00214526

Asthma

COMPLETED NA

Asthma Intervention Research 2 (AIR2) Trial

NCT00231114

Asthma

COMPLETED NA

A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers

NCT00411814

Asthma

COMPLETED PHASE1

Single Dose Study to Evaluate the Safety, and Efficacy of S-1226 (8%) in Subjects With Mild Atopic Asthma

NCT02334553

Asthma

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution)

Group Type EXPERIMENTAL

AIR645

Intervention Type DRUG

AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

2

Physiologic saline solution

Group Type PLACEBO_COMPARATOR

Physiologic saline solution

Intervention Type DRUG

Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AIR645

AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Intervention Type DRUG

Physiologic saline solution

Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Good General Health (with or without allergic rhinitis and/or controlled asthma)
* Non-smoker for at least 2 years
* Normal lung function (DLCO)
* Able to provide informed consent and to understand and comply with the requirements of the study

Exclusion Criteria

* Clinically significant medical history or condition which precludes participation
* Clinically significant ECG abnormality
* Clinically significant VS or PE abnormality
* Clinically significant screening lab abnormality
* Abnormal lung function (FEV1 \<80% predicted)
* Respiratory infection within 14 days of randomization
* HBV, HCV, or HIV
* Breastfeeding or pregnant female
* History of alcohol abuse or illicit drug use within past 24 months
* Use of any tobacco or nicotine-containing product within past 6 months
* Use of any herbal supplement, over-the-counter drug, or prescription drug that is not allowed per protocol
* Use of any investigational drug within past 30 days
* Use of any investigational monoclonal antibody or recombinant protein within past 90 days
* Donation of plasma within past 7 days
* Donation or loss of whole blood within past 56 days

* Simplified list of I/E criteria; unabridged list available upon request.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes