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Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma

Phase 1
Completed
Conditions
Asthma
Interventions
Drug: ABT-308
Drug: 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:

    1. A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
    2. BMI 18 to 29, inclusive.
  • Mild asthma patients:

    1. Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for > or = to 6 months
    2. 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.
    3. BMI 18 to 34, inclusive.
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Exclusion Criteria
  1. Asthma exacerbation within 8 weeks of Study Day 1.
  2. Clinically significant allergic reaction to any drug, biologic, food, or vaccine.
  3. History of allergic reaction or significant sensitivity to constituents of study drug.
  4. Receipt of any investigational product within 30 days or 5 half-lives (whichever is longer) prior to study drug administration.
  5. Subject is a smoker or has a history of smoking within the 6-month period preceding study drug administration.
  6. Current enrollment in another clinical study.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SC ABT-308 in asthmaticsABT-308ABT-308 multiple SQ doses in mild to moderate asthmatics
SC ABT-308 in asthmaticsPlaceboABT-308 multiple SQ doses in mild to moderate asthmatics
IV ABT-308 in healthy volunteersABT-308ABT-308 single escalating IV doses in healthy volunteers
IV ABT-308 in asthmaticsPlaceboABT-308 single escalating doses in mild to moderate asthmatics
IV ABT-308 in healthy volunteersPlaceboABT-308 single escalating IV doses in healthy volunteers
IV ABT-308 in asthmaticsABT-308ABT-308 single escalating doses in mild to moderate asthmatics
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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
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