Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
Phase 1
Completed
- Conditions
- Asthma
- Interventions
- Drug: ABT-308Drug: Placebo
- Registration Number
- NCT00986037
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
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.
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SC ABT-308 in asthmatics ABT-308 ABT-308 multiple SQ doses in mild to moderate asthmatics SC ABT-308 in asthmatics Placebo ABT-308 multiple SQ doses in mild to moderate asthmatics IV ABT-308 in healthy volunteers ABT-308 ABT-308 single escalating IV doses in healthy volunteers IV ABT-308 in asthmatics Placebo ABT-308 single escalating doses in mild to moderate asthmatics IV ABT-308 in healthy volunteers Placebo ABT-308 single escalating IV doses in healthy volunteers IV ABT-308 in asthmatics ABT-308 ABT-308 single escalating doses in mild to moderate asthmatics
- Primary Outcome Measures
Name Time Method Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments. 12 weeks after last dose
- Secondary Outcome Measures
Name Time Method Pharmacokinetics will be determined by measuring serum concentration of ABT-308. 12 weeks after last dose Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies. 12 weeks after last dose