A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma (AIR645-CS1)

Altair Therapeutics

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: AIR645; Drug: Physiologic saline solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658749

AIR645-CS1

Details and patient eligibility

About

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

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

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

Treatment:

Drug: AIR645

2

Placebo Comparator group

Description:

Physiologic saline solution

Treatment:

Drug: Physiologic saline solution