A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
Study Details
Study Description
Brief Summary
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group 1 LCB01-0371 800mg, QD |
Drug: LCB01-0371 800mg, QD
Oral administration
Other Names:
|
Experimental: Group 2 LCB01-0371 400mg, BID |
Drug: LCB01-0371 400mg, BID
Oral administration
Other Names:
|
Experimental: Group 3 LCB01-0371 800mg, BID |
Drug: LCB01-0371 800mg, BID
Oral administration
Other Names:
|
Active Comparator: Group 4 Tubes 3~5Tablet, QD |
Drug: Tubes 3~5Tablet, QD
Oral administration
Other Names:
|
Active Comparator: Group 5 Zyvox 600mg, BID |
Drug: Zyvox 600mg, BID
Oral administration
Other Names:
|
Experimental: Group 6 LCB01-0371 1200mg, QD |
Drug: LCB01-0371 1200mg, QD
Oral administration
Other Names:
|
Outcome Measures
Primary Outcome Measures
- EBA0-14 [V2(Baseline, Day 1), V9(Day 15)]
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15
Secondary Outcome Measures
- EBA0-2 [V2(Baseline, Day 1), V4(Day 3)]
The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3
- EBA2-14 [V4(Day 3), V9(Day 15)]
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15
- EBA2-7 [V4(Day 3), V6(Day 8)]
The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
-
The age of consent at the time of writing, only men and women under 75 years old over 19 years old
-
The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients
Exclusion Criteria:
-
Known history of Rifampicin or Isoniazid resistance
-
Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
-
Known History of nontuberculous mycobacteria positive
-
Other pulmonary disease which is impossible to participate in clinical trial except TB
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Asan Medical Center | Seoul | Korea, Republic of |
Sponsors and Collaborators
- LegoChem Biosciences, Inc
Investigators
- Principal Investigator: T.S Sim, M.D., Ph.D, Asan Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LCB01-0371-15-2-01