drugset / Trial / NCT03846648

CyPep-1 in Cutaneous Warts

NCT03846648

Phase 1 Completed 56 enrolled Centre for Human Drug Research, Netherlands
RandomizedParallel-groupDouble-blindTreatment

Summary

This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since this is a first-on-human study of a topical formulation, the first subjects will be monitored more frequently in order to establish the safety profile. Because clinical outcomes (i.e. reduction/clearance of the lesion) often require lengthy treatment / observation periods, the study design will primarily utilize clinical measurements of wart dimensions, along with HPV viral load as a biomarker of anti-viral effect.

Timeline

Start
2019-03-11
Primary completion
2019-12-20
Completion
2019-12-20

Drugs

EvaluationDrugModalityDoseRoute
Comparator CyPep-1 Peptide 1 % Topical

Indications