drugset / Trial / NCT01638611
A Study of Subcutaneous Doses of HIP2B in Healthy Male Subjects
RandomizedParallel-groupTriple-blindBasic science
Summary
HIP2B is the stabilized form of the Human proIslet Peptide (HIP). Human proIslet Peptide is the human homolog of Islet Neogenesis Associated Protein (INGAP) peptide, which has shown signals of efficacy in type 1 and type 2 diabetes mellitus. In a mouse model of diabetes, repeat dose treatment with HIP results in new islet formation and improvement in blood glucose measurements. HIP2B is being developed for the treatment of type 1 and type 2 diabetes mellitus. The present clinical trial protocol proposes the first administration of HIP2B to humans with the goal of exploring the tolerability, safety and PK of HIP2B following subcutaneous single ascending doses.
Timeline
- Start
- 2012-07
- Primary completion
- 2012-09
- Completion
- 2012-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | BTI-410 | Peptide | 60 mg | Subcutaneous |
| Comparator | BTI-410 | Peptide | 120 mg | Subcutaneous |
| Comparator | BTI-410 | Peptide | 240 mg | Subcutaneous |
| Comparator | BTI-410 | Peptide | 480 mg | Subcutaneous |
| Comparator | BTI-410 | Peptide | 720 mg | Subcutaneous |
Indications
No indication recorded.