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

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00658749

Acronym

AIR645-CS1

Enrollment

Registered

2008-04-15

Start date

2008-04-30

Completion date

2009-05-31

Last updated

2009-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

AIR645, Altair Therapeutics, IL4, IL13, IL-4, IL-13

Brief summary

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

Interventions

DRUGAIR645

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

DRUGPhysiologic saline solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Measures of the safety and tolerability of AIR645 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, pulmonary function tests, heart rhythm, and laboratory tests.	During dosing and for two weeks after dosing

Secondary

Measure	Time frame
Bioavailability	During dosing and for two weeks after dosing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026