Novartis Investigative Site
Raleigh, North Carolina, 27607, United States
NCT Number: NCT01568762
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.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Raleigh, North Carolina, 27607, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria may apply.
Intravenous infusion
Intravenous infusion
Intravenous infusion
Intravenous infusion
Time frame: 100 days
Adverse events will be determined by evaluating clinical, laboratory evaluations, impact on vital signs and impacts on ECGs
Time frame: Pre-dose, Day 71, 85 and 100
Blood will be collected to determine concentrations if anti-VAK964 antibodies
Time frame: Pre-dose, Day 71, 85 and 100
Blood will be collected to determine concentrations if anti-QAX576 antibodies
Time frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Blood will be collected for the measurement of VAK694 serum concentrations
Time frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Blood will be collected for the measurement of QAX576 concentrations
Time frame: Pre-dose, 1, 2, 4, 11, 24, 48, 96 hours and Days 8, 15, 29, 43, 57, 71, 85, 100
Blood samples will be collected to measure interleukin concetrations.
Novartis Pharmaceuticals
Industry
A Randomized, Double-blind, Placebo Controlled Study 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
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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