- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00986037
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
November 17, 2017 updated by: AbbVie
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
47
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: IV ABT-308 in asthmatics
ABT-308 single escalating doses in mild to moderate asthmatics
|
Single IV doses
Multiple SC doses x 3
Single IV dose
Multiple SC doses x 3
|
EXPERIMENTAL: SC ABT-308 in asthmatics
ABT-308 multiple SQ doses in mild to moderate asthmatics
|
Single IV doses
Multiple SC doses x 3
Single IV dose
Multiple SC doses x 3
|
EXPERIMENTAL: IV ABT-308 in healthy volunteers
ABT-308 single escalating IV doses in healthy volunteers
|
Single IV doses
Multiple SC doses x 3
Single IV dose
Multiple SC doses x 3
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
12 weeks after last dose
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
Time Frame: 12 weeks after last dose
|
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
|
12 weeks after last dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ACTUAL)
July 1, 2010
Study Registration Dates
First Submitted
September 25, 2009
First Submitted That Met QC Criteria
September 28, 2009
First Posted (ESTIMATE)
September 29, 2009
Study Record Updates
Last Update Posted (ACTUAL)
November 21, 2017
Last Update Submitted That Met QC Criteria
November 17, 2017
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M10-378
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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