drugset / Trial / NCT05829629

Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women

NCT05829629 ↗

Phase 1 Recruiting 20 enrolled BlueSky Immunotherapies GmbH
RandomizedParallel-groupTriple-blindTreatment

Summary

BS-02 is a randomised, double-blind, placebo-controlled, phase 1 dose escalation study to assess the safety, tolerability and immunogenicity of FluBHPVE6E7, in women infected with HPV-16. with cervical cytological evaluation negative for intraepithelial lesion or malignancy (NILM), atypical squamous cells of undetermined significance (ASC-US), low grade squamous intraepithelial lesion (LSIL), or low-grade cervical intraepithelial neoplasia (CIN1).

Timeline

Start
2023-09-12
Primary completion
2025-09
Completion
2025-11

Drugs

EvaluationDrugModalityDoseRoute
Subject FluBHPVE6E7 Vaccine 0.5 ml Other