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

Study Overview
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Brief Summary
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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.

Conditions
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Asthma

Intervention / Treatment
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* Drug: ABT-308
* Drug: ABT-308
* Drug: Placebo
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IV ABT-308 in asthmatics<br>ABT-308 single escalating doses in mild to moderate asthmatics | Drug: ABT-308<br>* Single IV doses<br>Drug: Placebo<br>* Single IV dose<br>|
| Experimental: SC ABT-308 in asthmatics<br>ABT-308 multiple SQ doses in mild to moderate asthmatics | Drug: ABT-308<br>* Multiple SC doses x 3<br>Drug: Placebo<br>* Multiple SC doses x 3<br>|
| Experimental: IV ABT-308 in healthy volunteers<br>ABT-308 single escalating IV doses in healthy volunteers | Drug: ABT-308<br>* Single IV doses<br>Drug: Placebo<br>* Single IV dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adverse events, Pharmacokinetics