Overview

A Trial to Evaluate the Efficacy and Safety of BLS-ILB-E710c in Patients With Cervical Intraepithelial Neoplasia 2/3 (CIN2/3)

Status:
Recruiting
Trial end date:
2020-08-01
Target enrollment:
0
Participant gender:
Female
Summary
This study evaluates the efficacy and safety of the experimental drug, BLS-ILB-E710c, in patients with Cervical Intraepithelial Neoplasia 2/3 (CIN2/3). 2/3 of participants will receive the experimental drug, while 1/3 of participants will receive placebo.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
BioLeaders Corporation
Criteria
Inclusion Criteria:

- Fertile female aged between 20 and 49

- Subjects who are infected with HPV 16 type only or with HPV 16 type and any other
types listed below

1) low risk type of HPV, 2) HPV 16-related type

- Subjects who are diagnosed as Cervical interaepithelial neoplasia 2/3 (CIN2/3) by
colposcopic biopsy within 6 weeks before enrollment

- All lesions must be observable by colposcopy and CIN2 or higher lesion must be less
than 1/2 in the transformation zone area

- Willing to use adequate contraception methods during the study period

- Eligible based on screening test results

- Normal electrocardiogram

- Voluntarily signed informed consent form

Exclusion Criteria:

- Subjects who are diagnosed with Carcinoma In Situ with microinvasion or suspicious
invation

- Presence of adenocarcinoma or glandular lesion in the cervix

- Subjects who are infected with HPV type 18-related type

- Subjects with autoimmune disease

- Current or prior treatment past 2 months with immunosuppressant therapies

- Hypersensitive to the investigational drug

- Subjects who currently have acute diseases that require medical attention

- Participation in other studies involving investigational drug(s) or investigational
device(s) within 3 months

- Currently having chronic pancreatitis or diagnosed with acute pancreatitis

- Currently having underlying diseases including inflammatory intestinal diseases and
tumors, ulcer, bleeding or puncture in the gastrointestinal tract

- Pregnant or breastfeeding

- Subjects with active or inactive hepatitis, or infectious disease

- History of HIV infection

- History of therapeutic HPV vaccination

- Subjects who require continuous use of antibiotics

- Administration of blood product within 3 months before signing informed consent form

- History of vaccination within 2 months before signing informed consent form (4 months
in case of live vaccine)