Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

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Uterine Cervical Dysplasia

Neoplasms, Glandular and Epithelial

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Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

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Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Micronutrients

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Vitamins

Ascorbic Acid

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Immunologic Factors

Vitamin C

* Drug: BLS_ILB_E710c 500mg
* Dosage and duration: 2 capsules per day for 20 days (week 1,2,4 \& 8)

* Drug: BLS_ILS_E710c 1000mg
* Dosage and duration: 4 capsules per day for 20 days (week 1,2,4 \& 8)

* Drug: BLS_ILS_E710c 1500mg
* Dosage and duration: 6 capsules per day for 20 days (week 1,2,4 \& 8)

- 2 capsules per day for 20 days (week 1,2,4 \& 8)

BLS_ILS_E710c 500mg

- 4 capsules per day for 20 days (week 1,2,4 \& 8)

BLS_ILB_710c 1000mg

- 6 capsules per day for 8 weeks (week 1,2,4 \& 8)

BLS_ILS_E710c 1500mg

Jae-Kwan Lee, MD, PhD

Tae Jin Kim, MD, PhD

Jong Sup Park, MD, PhD

Chi-Heum Cho, MD, PhD

Jong Hyeok Kim, MD, PhD

The purpose of this study is to determine the efficacy and the safety of BLS-ILB-E710c for the the fertile women with Cervical Intraepithelial Neoplasia (CIN3).

This study is to see the regression rate of Cervical Intraepithelial Neoplasia (CIN3) and to see the inducement of Cytotoxic T Lymphocyte.

The First treatment group will be administered with BLS-ILB-E710c 500mg for 8 weeks followed by 1 week observation The Second treatment group will be administered with BLS-ILB-E710c 1000mg for 8 weeks followed by 1 week observation The Third treatment group will be administered with BLS-ILB-E710c 1500mg for 8 weeks followed by 1 week observation The fourth treatment group will be administered with BLS-ILB-E710c Optimum dose for 8 weeks followed by 8 weeks observation

Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

A Phase 1/2a Trial to Evaluate the Efficacy and the Safety of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)

Dose Limiting Toxicity(DLT) is assessed by NCI-CTC version 4.0

Regression rate will be assessed at the time of screening and 9 weeks(option), 16 weeks. Regression means the change from the stage of CIN1 to normal

Reid Colposcopic Index will be assessed at the time of screening,4 weeks 9.

Reid Colposcopic Index will be assessed at the time of screening,4 weeks, 9 weeks, 12 weeks, 16 weeks

Serum anti-E7 antibody will be assessed at the time of 1 week, 9 weeks, 16 weeks.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)	NCT02195089	Cervical Intrae...	BLS_ILS_E710c 5... BLS_ILB_710c 10... BLS_ILS_E710c 1...	20 Years - 50 Years	BioLeaders Corporation
Efficacy and Safety Study of BLS_ILB_E710c for the Fertile Women With Cervical Intraepithelial Neoplasia(CIN3)	NCT02195089	Cervical Intrae...	BLS_ILS_E710c 5... BLS_ILB_710c 10... BLS_ILS_E710c 1...	20 Years - 50 Years	BioLeaders Corporation

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