Trials / Completed
CompletedNCT02195089
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)
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- BioLeaders Corporation · Industry
- Sex
- Female
- Age
- 20 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
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).
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BLS_ILS_E710c 500mg | \- 2 capsules per day for 20 days (week 1,2,4 \& 8) |
| DRUG | BLS_ILB_710c 1000mg | \- 4 capsules per day for 20 days (week 1,2,4 \& 8) |
| DRUG | BLS_ILS_E710c 1500mg | \- 6 capsules per day for 8 weeks (week 1,2,4 \& 8) |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-03-01
- Completion
- 2016-04-01
- First posted
- 2014-07-21
- Last updated
- 2016-04-19
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02195089. Inclusion in this directory is not an endorsement.