MedTrace Logo

Safety Assessment of P2Et Extract in Healthy Voluntary Subjects in Colombia

NCT03663881 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-03-13

No results posted yet for this study

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.

Conditions

  • Toxicity
  • Safety Issues

Interventions

DRUG

P2Et extract

P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.

Sponsors & Collaborators

  • Pontificia Universidad Javeriana

    collaborator OTHER

  • Hospital Universitario San Ignacio

    lead OTHER

Principal Investigators

  • Lilian Torregrosa Almonacid, MD · Surgeon

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-30
Primary Completion
2020-05-15
Completion
2020-05-15

Countries

  • Colombia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03663881 on ClinicalTrials.gov