AsthmaPhase 1AIR645-CS1NCT00658749
A Phase 1 Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
A Phase 1 study testing AIR645 and Physiologic saline solution in people with Asthma, run by Altair Therapeutics, Inc. at 1 site in United States.
Trial summary
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AIR645 and Physiologic saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to May 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
Contract Research Organization (CRO) appointed by Altair Therapeutics--Altair's offices are in:
San Diego, California, 92130
About this study
Official title: A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
- Conditions
- Asthma
- Being tested
- AIR645, Physiologic saline solution
- Keywords
- AIR645, Altair Therapeutics, IL4, IL13, IL-4, IL-13
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIR645Drug
AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
Physiologic saline solutionDrug
Placebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) Receives: Drug: AIR645 |
| 2 | Placebo comparator | Physiologic saline solution Receives: Drug: Physiologic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During dosing and for two weeks after dosing
Secondary outcomes (1)
Bioavailability
Measured: During dosing and for two weeks after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altair Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mike Hodges, MD, Study director, Altair Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658749
- Sponsor's protocol ID
- AIR645-CS1
- Acronym
- AIR645-CS1
- Status last verified
- Jun 2009
- First submitted
- 11 Apr 2008
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study of AIR645 in Healthy Subjects and Subjects With Controlled Asthma
- ClinicalTrials.gov ID
- NCT00658749
- Acronym / sponsor ID
- AIR645-CS1 / AIR645-CS1
- Conditions
- Asthma
- Keywords
- AIR645, Altair Therapeutics, IL4, IL13, IL-4, IL-13
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Altair Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 15 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase one study to evaluate the safety, tolerability, and bioavailability of nebulized AIR645.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AIR645AIR645 (an IL-4/IL-13 dual cytokine signaling inhibitor) solution (diluent: physiologic saline solution) |
| 2 | Placebo comparator | Drug: Physiologic saline solutionPhysiologic saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIR645AIR645 (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days. | Drug | 1 |
| Physiologic saline solutionPlacebo (blinded) by nebulization, range of doses, maximum of one dose per day, maximum of 6 doses in 22 days. | Drug | 2 |
Primary outcome
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.
Time frame: During dosing and for two weeks after dosing
1 secondary outcome
Bioavailability
Time frame: During dosing and for two weeks after dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Hodges, MD study director
Altair Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AIR645 and Physiologic saline solution in people with Asthma, run by Altair Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: During dosing and for two weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2009.