drugset / Trial / NCT02354534
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Phase 1
Completed
30 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Frantz Viral Therapeutics, LLC · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase I research protocol is designed to assess immunogenicity and clinical endpoints in patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The protocol tests the use of artesunate in suppository formulation applied intravaginally in patients with cervical dysplasia (CIN2/3). The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility of intravaginal administration of artesunate in health women with CIN2/3.
Timeline
- Start
- 2015-02
- Primary completion
- 2018-07
- Completion
- 2018-11-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Artesunate | Small molecule | 50 mg | Intravitreal |
| Subject | Artesunate | Small molecule | 200 mg | Intravitreal |