AsthmaPhase 1NCT00986037
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
A Phase 1 study testing ABT-308 in people with Asthma, run by AbbVie.
Trial summary
The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- ABT-308
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jul 2010
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers:
- A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
- BMI 18 to 29, inclusive.
- Mild asthma patients:
- Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for > or = to 6 months
- A condition of good health (than mild to moderate asthma) based upon the results of medical history, physical examination, vital signs laboratory profile and EDG.
- BMI 18 to 34, inclusive.
Who cannot join
- Asthma exacerbation within 8 weeks of Study Day 1.
- Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
- History of allergic reaction or significant sensitivity to constituents of study drug.
- Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
- Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
- Current enrollment in another clinical study.
About this study
The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.
- Conditions
- Asthma
- Being tested
- ABT-308, Placebo
- Keywords
- Adverse events, Pharmacokinetics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-308Drug
Single IV doses
ABT-308Drug
Multiple SC doses x 3
PlaceboDrug
Single IV dose
PlaceboDrug
Multiple SC doses x 3
| Study group | Role | What they receive |
|---|---|---|
| IV ABT-308 in asthmatics | Experimental | ABT-308 single escalating doses in mild to moderate asthmatics Receives: Drug: ABT-308; Drug: Placebo |
| SC ABT-308 in asthmatics | Experimental | ABT-308 multiple SQ doses in mild to moderate asthmatics Receives: Drug: ABT-308; Drug: Placebo |
| IV ABT-308 in healthy volunteers | Experimental | ABT-308 single escalating IV doses in healthy volunteers Receives: Drug: ABT-308; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
Measured: 12 weeks after last dose
Secondary outcomes (2)
Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
Measured: 12 weeks after last dose
Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.
Measured: 12 weeks after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Andrew Campbell, MD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986037
- Sponsor's protocol ID
- M10-378
- Status last verified
- Mar 2011
- First submitted
- 25 Sep 2009
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Tripp CS, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, Wu C, Cherniack AD, Kim K. RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 alpha1 and alpha2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study. Adv Ther. 2017 Jun;34(6):1364-1381. doi: 10.1007/s12325-017-0525-8. Epub 2017 Apr 28.
PubMed 28455782
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
- ClinicalTrials.gov ID
- NCT00986037
- Acronym / sponsor ID
- M10-378
- Conditions
- Asthma
- Keywords
- Adverse events, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- First posted
- 29 Sep 2009 (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.
The primary purpose of this study is to determine the safety, tolerability and pharmacokinetics of ABT-308 in healthy volunteers and patients with mild to moderate controlled asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV ABT-308 in asthmatics | Experimental | Drug: ABT-308, Drug: PlaceboABT-308 single escalating doses in mild to moderate asthmatics |
| SC ABT-308 in asthmatics | Experimental | Drug: ABT-308, Drug: PlaceboABT-308 multiple SQ doses in mild to moderate asthmatics |
| IV ABT-308 in healthy volunteers | Experimental | Drug: ABT-308, Drug: PlaceboABT-308 single escalating IV doses in healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy volunteers:
- Mild asthma patients:
Key exclusion criteria (6 listed)
- Asthma exacerbation within 8 weeks of Study Day 1.
- Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
- History of allergic reaction or significant sensitivity to constituents of study drug.
- Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
- Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
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 |
|---|---|---|
| ABT-308Single IV doses | Drug | IV ABT-308 in asthmatics, IV ABT-308 in healthy volunteers |
| ABT-308Multiple SC doses x 3 | Drug | SC ABT-308 in asthmatics |
| PlaceboSingle IV dose | Drug | IV ABT-308 in asthmatics, IV ABT-308 in healthy volunteers |
| PlaceboMultiple SC doses x 3 | Drug | SC ABT-308 in asthmatics |
Primary outcome
Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
Time frame: 12 weeks after last dose
2 secondary outcomes
Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
Time frame: 12 weeks after last dose
Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.
Time frame: 12 weeks after last dose
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 21 Nov 2017.
- Results publication: PubMed 28455782Tripp CS, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, Wu C, Cherniack AD, Kim K. RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 alpha1 and alpha2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study. Adv Ther. 2017 Jun;34(6):1364-1381. doi: 10.1007/s12325-017-0525-8. Epub 2017 Apr 28.
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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.
Andrew Campbell, MD study director
Abbott
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABT-308 in people with Asthma, run by AbbVie.
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 7 inclusion and 6 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 21 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments. (time frame: 12 weeks after last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00986037, which also lists 1 linked publication.
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 21 Nov 2017.