Microdose and First-In-Human (FIH) Study of Recombinant Human Placental Alkaline Phosphatase (hRESCAP)
Summary
In the present study human recombinant placental alkaline phosphatase (hRESCAP) will be investigated. Alkaline Phosphatase is naturally present in the body and reported to use lipopolysaccharde (LPS, bacterial endotoxins) and extracellular nucleotides leaking from damaged and ischemic cells as physiological substrates. The LPS-substrate prevalence makes alkaline phosphatase an interesting novel therapeutic agent in the treatment of LPS-mediated diseases. A bovine homologue of this protein (bovine intestinal alkaline phosphatase, BIAP) has previously been investigated for treatment of acute inflammatory responses such as sepsis, and was shown to be safe in humans. hRESCAP, which will be investigated in the current study, is expected to have a longer half-life in humans than the previously investigated BIAP, due to the fact that it is more sialylated. The possibility to increase the t1/2 to days instead of minutes enables treatment of chronic diseases.
Timeline
- Start
- 2013-06
- Primary completion
- 2013-07
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | hRESCAP | Protein / enzyme biologic | 414 ug | Intravenous |
| Comparator | hRESCAP | Protein / enzyme biologic | 2480 ug | Intravenous |
| Comparator | hRESCAP | Protein / enzyme biologic | 5300 ug | Intravenous |
| Comparator | hRESCAP | Protein / enzyme biologic | 30 mmol | Intravenous |
Indications
No indication recorded.