Status:
COMPLETED
Assessment of the Safety of ABT-308 in Healthy Volunteers and Subjects With Asthma
Lead Sponsor:
AbbVie
Conditions:
Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00986037
Start Date
October 1 2009
Last Update
November 21 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.