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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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IV ABT-308 in asthmatics

ABT-308 single escalating doses in mild to moderate asthmatics

Group Type EXPERIMENTAL

ABT-308

Intervention Type DRUG

Single IV doses

Placebo

Intervention Type DRUG

Single IV dose

SC ABT-308 in asthmatics

ABT-308 multiple SQ doses in mild to moderate asthmatics

Group Type EXPERIMENTAL

ABT-308

Intervention Type DRUG

Multiple SC doses x 3

Placebo

Intervention Type DRUG

Multiple SC doses x 3

IV ABT-308 in healthy volunteers

ABT-308 single escalating IV doses in healthy volunteers

Group Type EXPERIMENTAL

ABT-308

Intervention Type DRUG

Single IV doses

Placebo

Intervention Type DRUG

Single IV dose

Interventions

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ABT-308

Single IV doses

Intervention Type DRUG

ABT-308

Multiple SC doses x 3

Intervention Type DRUG

Placebo

Single IV dose

Intervention Type DRUG

Placebo

Multiple SC doses x 3

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes