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)