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

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ClinicalTrials.gov Identifier: NCT00986037
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : November 21, 2017
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: ABT-308 Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 47 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : October 2009
Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions

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: Placebo
Single IV dose
Experimental: SC ABT-308 in asthmatics
ABT-308 multiple SQ doses in mild to moderate asthmatics
Drug: ABT-308
Multiple SC doses x 3
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: Placebo
Single IV dose


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Pharmacokinetics will be determined by measuring serum concentration of ABT-308. [ Time Frame: 12 weeks after last dose ]
  2. Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies. [ Time Frame: 12 weeks after last dose ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00986037


Sponsors and Collaborators
AbbVie
Investigators
Study Director: Andrew Campbell, MD Abbott
More Information

Publications:
Responsible Party: Catherine Tripp MD PhD, Abbott
ClinicalTrials.gov Identifier: NCT00986037     History of Changes
Other Study ID Numbers: M10-378
First Posted: September 29, 2009    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: March 2011

Keywords provided by AbbVie:
Adverse events
Pharmacokinetics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases