drugset / Trial / NCT02312180
A Phase 1 Study of ProMetic Plasminogen (Human) Intravenous in Adults and Children With Plasminogen Deficiency
Non-randomizedSingle-groupOpen-labelTreatment
Summary
ProMetic is intiitating a first-in-man study entitled "A Phase 1, Dose Escalation, and Pharmacokinetic Study of ProMetic Plasminogen Administered as Intravenous Infusion in Adults and Children with Hypoplasminogenemia". The general objectives of this clinical study, (Protocol #2002C005G), are to determine the optimal dose and interval required to support the planned Phase 2/3 study and to investigate initial safety and tolerability.
Timeline
- Start
- 2014-12
- Primary completion
- 2015-12
- Completion
- 2016-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plasminogen (Human) | Protein / enzyme biologic | 2 mg/kg | Intravenous |
| Subject | Plasminogen (Human) | Protein / enzyme biologic | 6 mg/kg | Intravenous |
| Subject | Plasminogen (Human) | Protein / enzyme biologic | 12 mg/kg | Intravenous |