To Compare the Safety, Tolerability, and Pharmacokinetics of QBX258 in Patients With Asthma

NCT01568762 | Completed Phase 1

• 1 other identifier: CQBX258X2101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to compare the safety, tolerability, and pharmacokinetics of QBX258 (sequential administration of a fixed dose of VAK694 and single ascending doses of QAX576) in patients with well-controlled mild to moderate asthma.

Conditions

Asthma

Keywords

Asthma; VAK694; QAX576; QBX258; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs

  100 days

Secondary Outcomes (5)

• Concentration of serum anti-VAK694 antibodies

  Pre-dose, Day 71, 85 and 100

• Concentration of serum anti-QAX576 antibodies

  Pre-dose, Day 71, 85 and 100

• Area under the serum concentration curve for VAK694

  Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100

• Area under the serum concentration curve for QAX576

  Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100

• Change in interleukin concentrations

  Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100

Study Arms (4)

VAK694

EXPERIMENTAL

VAK694 was administered as a 1 hour intravenous infusion

Drug: VAK694

VAK694 Placebo

PLACEBO COMPARATOR

VAK694 placebo was administered as a one hour intravenous infusion

Drug: VAK694 placebo

QAX576

EXPERIMENTAL

QAX576 was administered intravenously as a 2 hour infusion

Drug: QAX576

QAX576 placebo

PLACEBO COMPARATOR

QAX576 placebo was administered as a 2 hour intravenous infusion

Drug: QAX576 placebo

Interventions

VAK694 DRUG

Intravenous infusion

VAK694

VAK694 placebo DRUG

Intravenous infusion

VAK694 Placebo

QAX576 DRUG

Intravenous infusion

QAX576

QAX576 placebo DRUG

Intravenous infusion

QAX576 placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects age 18-60 years (inclusive)
• Well controlled mild to moderate atopic asthma
• Female subjects must be post-menopausal or surgically sterile
• Male subjects must be using two methods of contraception
• Subjects must have a positive skin prick test to one or more common airborne allergen

You may not qualify if:

• Participation in any clinical investigation or use of other investigational drugs at time of enrollment
• A history of clinically significant ECG abnormalities
• History of malignancy of any organ system
• Smokers (use of tobacco products in the previous 3 months)
• Use of prescription drugs other than those required for control and relief of asthma
• Use of oral steroids within 12 weeks prior to dosing
• FEVI \< 80% predicted at screening or baseline
• Use of albuterol more than twice a week for relief of asthma
• Patients suffering from active hay fever at baseline or likely to require treatment during the study
• History of chronic respiratory disease other than asthma or chronic allergic rhinitis
• Emergency room visit within 6 weeks of screening due to asthma
• Hospitalization for asthma in the last year
• History of intubation/assisted ventilation for asthma in the last 5 years
• Administration of live vaccines within the preceding month

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Raleigh, North Carolina, 27607, United States

Location

Related Links

• Results forCQBX258X2101 can be found on the Novartis Clinical Trial Results Website

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2011
• Last Updated: December 21, 2020

Record last verified: 2012-03

Locations

US (1)