A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

Study Overview
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Brief Summary
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A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

Detailed Description
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This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.

Official Title
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A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial to Evaluate the EBA, Safety and PK of Orally Administered LCB01-0371 in Adult Patients With Smear-positive Pulmonary Tuberculosis

Conditions
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Pulmonary Tuberculosis

Intervention / Treatment
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* Drug: LCB01-0371 800mg, QD
* Drug: LCB01-0371 400mg, BID
* Drug: LCB01-0371 800mg, BID
* Drug: Tubes 3 5Tablet, QD
* Drug: Zyvox 600mg, BID
* Drug: LCB01-0371 1200mg, QD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>LCB01-0371 800mg, QD | Drug: LCB01-0371 800mg, QD<br>* Oral administration<br>* Other names: LCB01-0371;|
| Experimental: Group 2<br>LCB01-0371 400mg, BID | Drug: LCB01-0371 400mg, BID<br>* Oral administration<br>* Other names: LCB01-0371;|
| Experimental: Group 3<br>LCB01-0371 800mg, BID | Drug: LCB01-0371 800mg, BID<br>* Oral administration<br>* Other names: LCB01-0371;|
| Active Comparator: Group 4<br>Tubes 3 5Tablet, QD | Drug: Tubes 3 5Tablet, QD<br>* Oral administration<br>* Other names: Tubes Tablet;|
| Active Comparator: Group 5<br>Zyvox 600mg, BID | Drug: Zyvox 600mg, BID<br>* Oral administration<br>* Other names: Zyvox Tablet;|
| Experimental: Group 6<br>LCB01-0371 1200mg, QD | Drug: LCB01-0371 1200mg, QD<br>* Oral administration<br>* Other names: LCB01-0371;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EBA0-14 | The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15 | V2(Baseline, Day 1), V9(Day 15) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EBA0-2 | The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3 | V2(Baseline, Day 1), V4(Day 3) | 
| EBA2-14 | The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15 | V4(Day 3), V9(Day 15) | 
| EBA2-7 | The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8 | V4(Day 3), V6(Day 8) |