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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Abbott; AbbVie
• Treatments: Antibodies, Monoclonal

Criteria

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.

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.