drugset / Trial / NCT04539340
A Multi-cohort Study of the Tolerance, Safety, and Pharmacokinetics of GNR-055 in Healthy Volunteers
Non-randomizedSequentialOpen-labelTreatment
Summary
It is a phase I open-label single-dose, dose-escalation cohort study to evaluate of the tolerance, safety, and pharmacokinetics of GNR-055 in healthy volunteers
Timeline
- Start
- 2020-02-28
- Primary completion
- 2020-09-08
- Completion
- 2020-09-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GNR-055 | Protein / enzyme biologic | 0.3 mg/kg | Intravenous |
| Subject | GNR-055 | Protein / enzyme biologic | 0.5 mg/kg | Intravenous |
| Subject | GNR-055 | Protein / enzyme biologic | 1 mg/kg | Intravenous |
| Subject | GNR-055 | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | GNR-055 | Protein / enzyme biologic | 3 mg/kg | Intravenous |