drugset / Trial / NCT02840708
SK-1401 (rhGM-CSF Agent for Inhalation) GM-CSF Inhalation Pharmacokinetic Study
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Objective: Evaluate Pharmacokinetics and determine the safety of GM-CSF single dose inhalation. Study Design: Pharmacokinetic open study
Timeline
- Start
- 2016-05
- Primary completion
- 2016-12
- Completion
- 2017-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | sargramostim | Protein / enzyme biologic | 125 ug | Inhaled |
| Comparator | sargramostim | Protein / enzyme biologic | 250 ug | Inhaled |
| Comparator | sargramostim | Protein / enzyme biologic | 500 ug | Inhaled |