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

Asthma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986037
• Other study ID #: M10-378
• Status: Completed
• Phase: Phase 1
• First received: September 25, 2009
• Last updated: November 17, 2017
• Start date: October 2009

Study information

• Verified date: March 2011
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ABT-308
Single IV doses
• ABT-308
Multiple SC doses x 3
• Placebo
Single IV dose
• Placebo
Multiple SC doses x 3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

References & Publications (1)

Tripp CS, Cuff C, Campbell AL, Hendrickson BA, Voss J, Melim T, Wu C, Cherniack AD, Kim K. RPC4046, A Novel Anti-interleukin-13 Antibody, Blocks IL-13 Binding to IL-13 a1 and a2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Fi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics will be determined by measuring serum concentration of ABT-308.		12 weeks after last dose
Secondary	Immunogenicity will be determined by measuring serum concentrations of anti-ABT-308 antibodies.		12 weeks after last dose