Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia
Status:
Unknown status
Trial end date:
2020-05-01
Target enrollment:
Participant gender:
Summary
Caesalpinia spinosa extract is rich in gallotannins and other well characterized polyphenols
and has a major antioxidant activity. The extract shows immunomodulatory activity in healthy
animals and anti-tumor activity in animals with breast cancer and melanoma as well.
The use of P2Et in animals with tumors shows a synergistic effect with doxorubicin in
drug-resistant cell lines. In addition, an increase in survival of transplanted animals with
a TS/A breast cancer tumor model and treated with P2Et, in conjunction with calreticulin
increase is observed.
This open-label, single arm, Phase 1 study intends to assess the safety of P2Et extract
obtained from Caesalpinia spinosa, with dose escalation, in healthy voluntary participants in
Colombia.