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
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