drugset / Trial / NCT01362036
Phase I Study Evaluating TXA127 in Low/Intermediate-1 Risk Myelodysplastic Syndrome and Thrombocytopenia
NaSingle-groupOpen-labelTreatment
Summary
Phase 1, single-center, open-label, sequential cohort dose escalation study. This is a 3 + 3 design study involving at least 3 subjects in ascending dose cohorts, with subjects participating up to 10 weeks. The overall study objectives are to evaluate the safety and tolerability of TXA127 in thrombocytopenic subjects with low or intermediate-1 risk MDS. Evaluation of the platelet response and the erythroid and granulocytic responses to TXA127 will provide preliminary efficacy data.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-04
- Completion
- 2012-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | talfirastide | Peptide | 300 ug/kg | Subcutaneous |
| Subject | talfirastide | Peptide | 600 ug/kg | Subcutaneous |
| Subject | talfirastide | Peptide | 900 ug/kg | Subcutaneous |