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

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00986037
• Collaborator: (none)
• Enrollment: 47
• Arms: 3

Study Details

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: ABT-308; Drug: Placebo; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Jul 1, 2010

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. [12 weeks after last dose]

Secondary Outcome Measures

1. Pharmacokinetics will be determined by measuring serum concentration of ABT-308. [12 weeks after last dose]

2. Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies. [12 weeks after last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Andrew Campbell, MD, Abbott

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00986037
• Other Study ID Numbers: M10-378
• First Posted: Sep 29, 2009
• Last Update Posted: Nov 21, 2017
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: Adverse events; Pharmacokinetics
• Additional relevant MeSH terms: Asthma; Antibodies, Monoclonal

Study Results

No Results Posted as of Nov 21, 2017