A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
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ClinicalTrials.gov Identifier: NCT02836483 |
Recruitment Status :
Completed
First Posted : July 19, 2016
Last Update Posted : February 6, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Tuberculosis | 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 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 79 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | December 10, 2016 |
Actual Primary Completion Date : | July 1, 2019 |
Actual Study Completion Date : | July 1, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
LCB01-0371 800mg, QD
|
Drug: LCB01-0371 800mg, QD
Oral administration
Other Name: LCB01-0371 |
Experimental: Group 2
LCB01-0371 400mg, BID
|
Drug: LCB01-0371 400mg, BID
Oral administration
Other Name: LCB01-0371 |
Experimental: Group 3
LCB01-0371 800mg, BID
|
Drug: LCB01-0371 800mg, BID
Oral administration
Other Name: LCB01-0371 |
Active Comparator: Group 4
Tubes 3~5Tablet, QD
|
Drug: Tubes 3~5Tablet, QD
Oral administration
Other Name: Tubes Tablet |
Active Comparator: Group 5
Zyvox 600mg, BID
|
Drug: Zyvox 600mg, BID
Oral administration
Other Name: Zyvox Tablet |
Experimental: Group 6
LCB01-0371 1200mg, QD
|
Drug: LCB01-0371 1200mg, QD
Oral administration
Other Name: LCB01-0371 |
- EBA0-14 [ Time Frame: 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
- EBA0-2 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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

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Ages Eligible for Study: | 19 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02836483
Korea, Republic of | |
Asan Medical Center | |
Seoul, Korea, Republic of |
Principal Investigator: | T.S Sim, M.D., Ph.D | Asan Medical Center |
Responsible Party: | LegoChem Biosciences, Inc |
ClinicalTrials.gov Identifier: | NCT02836483 |
Other Study ID Numbers: |
LCB01-0371-15-2-01 |
First Posted: | July 19, 2016 Key Record Dates |
Last Update Posted: | February 6, 2020 |
Last Verified: | February 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Tuberculosis Tuberculosis, Pulmonary Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Infections Respiratory Tract Infections Lung Diseases |
Respiratory Tract Diseases Linezolid Delpazolid Oxazolidinones Anti-Bacterial Agents Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |