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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00986037
First received: September 25, 2009
Last updated: April 12, 2011
Last verified: March 2011
  Purpose

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 Intervention Phase
Asthma
Drug: ABT-308
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics will be determined by measuring serum concentration of ABT-308. [ Time Frame: 12 weeks after last dose ] [ Designated as safety issue: No ]
  • Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies. [ Time Frame: 12 weeks after last dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 47
Study Start Date: October 2009
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00986037

Locations
United States, Arizona
Site Reference ID/Investigator# 22663
Tempe, Arizona, United States, 85283
United States, California
Site Reference ID/Investigator# 22602
Cypress, California, United States, 90630
Sponsors and Collaborators
Abbott
Investigators
Study Director: Andrew Campbell, MD Abbott
  More Information

No publications provided

Responsible Party: Catherine Tripp MD PhD, Abbott
ClinicalTrials.gov Identifier: NCT00986037     History of Changes
Other Study ID Numbers: M10-378
Study First Received: September 25, 2009
Last Updated: April 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
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

ClinicalTrials.gov processed this record on September 22, 2014