drugset / Trial / NCT04923282
Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects
RandomizedSequentialQuadruple-blindTreatment
Summary
Clinical Phase 1 study to investigate the pharmacokinetics and to assess the safety and tolerability of recAP after single and multiple intravenous doses in healthy Japanese subjects.
Timeline
- Start
- 2021-05-07
- Primary completion
- 2021-07-08
- Completion
- 2021-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Recombinant Human Alkaline Phosphatase | Protein / enzyme biologic | 0.8 mg/kg | Intravenous |
| Comparator | Recombinant Human Alkaline Phosphatase | Protein / enzyme biologic | 1.6 mg/kg | Intravenous |
| Comparator | Recombinant Human Alkaline Phosphatase | Protein / enzyme biologic | 3.2 mg/kg | Intravenous |
Indications
No indication recorded.