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

NCT00986037 | Completed Phase 1

• 1 other identifier: M10-378
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

Adverse events; Pharmacokinetics

Outcome Measures

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.

  12 weeks after last dose

Secondary Outcomes (2)

• 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

Study Arms (3)

IV ABT-308 in asthmatics

EXPERIMENTAL

ABT-308 single escalating doses in mild to moderate asthmatics

Drug: ABT-308; Drug: Placebo

SC ABT-308 in asthmatics

EXPERIMENTAL

ABT-308 multiple SQ doses in mild to moderate asthmatics

Drug: ABT-308; Drug: Placebo

IV ABT-308 in healthy volunteers

EXPERIMENTAL

ABT-308 single escalating IV doses in healthy volunteers

Drug: ABT-308; Drug: Placebo

Interventions

ABT-308 DRUG

Single IV doses

IV ABT-308 in asthmatics; IV ABT-308 in healthy volunteers

Placebo DRUG

Single IV dose

IV ABT-308 in asthmatics; IV ABT-308 in healthy volunteers

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Related 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 alpha1 and alpha2 Receptors: A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation First-in-Human Study. Adv Ther. 2017 Jun;34(6):1364-1381. doi: 10.1007/s12325-017-0525-8. Epub 2017 Apr 28.

  PMID: 28455782 RESULT

MeSH Terms

Conditions

Asthma

Interventions

cendakimab

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Campbell, MD

  Abbott

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 29, 2009
• Study Start: October 1, 2009
• Primary Completion: July 1, 2010
• Last Updated: November 21, 2017

Record last verified: 2011-03