drugset / Trial / NCT01197287

Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients

NCT01197287 ↗

Phase 1 Completed 76 enrolled Novartis Pharmaceuticals
RandomizedCrossoverDouble-blindTreatment

Summary

There are three elements to this study: * Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned in healthy volunteers. * Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of QAK423 are planned in COPD patients. * Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients. Repeat dosing is planned in COPD patients.

Timeline

Start
2004-05
Primary completion
2005-02
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject QAK423A Unknown — —