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

November 17, 2017 updated by: AbbVie
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

47

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability will be determined by evaluation of adverse events, vital sign monitoring, physical examination, electrocardiograms, lung function and laboratory assessments.
Time Frame: 12 weeks after last dose
12 weeks after last dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics will be determined by measuring serum concentration of ABT-308.
Time Frame: 12 weeks after last dose
12 weeks after last dose
Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.
Time Frame: 12 weeks after last dose
12 weeks after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (ESTIMATE)

September 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

November 21, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-378

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Asthma

Clinical Trials on ABT-308

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe