drugset / Trial / NCT05829629
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FluBHPVE6E7 | Vaccine | 0.5 ml | Other |