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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00986037

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 I

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:

MedlinePlus related topics: Asthma

U.S. FDA Resources

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:

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.

Contacts and Locations

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 February 09, 2012