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OpenTrials
Completed

NCT Number: NCT00986037

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy volunteers:
  • A condition of good health based upon the results of medical history, physical examination, vital signs, laboratory profile and ECG.
  • BMI 18 to 29, inclusive.
  • Mild asthma patients:
  • Diagnosis of well-controlled, mild to moderate asthma by GINA guidelines for > or = to 6 months
  • 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.
  • 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.

Treatment and study plan

ABT-308

Drug

Single IV doses

Placebo

Drug

Single IV dose

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
First posted
Sep 29, 2009
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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