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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00986037

Enrollment

Registered

2009-09-29

Start date

2009-10-31

Completion date

Unknown

Last updated

2017-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Adverse events, Pharmacokinetics

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.

Interventions

DRUGABT-308

Single IV doses

DRUGPlacebo

Single IV dose

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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.

Design outcomes

Primary

Measure	Time frame
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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026