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

This study is currently recruiting participants.
Verified August 2017 by LegoChem Biosciences, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02836483
First Posted: July 19, 2016
Last Update Posted: August 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
LegoChem Biosciences, Inc
  Purpose
A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

Condition Intervention 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 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by LegoChem Biosciences, Inc:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 64
Actual Study Start Date: December 10, 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent
  2. The age of consent at the time of writing, only men and women under 70 years old over 19 years old
  3. The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients

Exclusion Criteria:

  1. Known history of Rifampicin or Isoniazid resistance
  2. Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials
  3. Known History of nontuberculous mycobacteria positive
  4. Other pulmonary disease which is impossible to participate in clinical trial except TB
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: T.S. Sim, M.D., Ph.D 82-2-3010-3892 shimts@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: T.S. Sim, M.D., Ph.D    82-2-3010-3892    shimts@amc.seoul.kr   
Sponsors and Collaborators
LegoChem Biosciences, Inc
Investigators
Principal Investigator: T.S Sim, M.D., Ph.D Asan Medical Center
  More Information

Responsible Party: LegoChem Biosciences, Inc
ClinicalTrials.gov Identifier: NCT02836483     History of Changes
Other Study ID Numbers: LCB01-0371-15-2-01
First Submitted: July 5, 2016
First Posted: July 19, 2016
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tuberculosis
Tuberculosis, Pulmonary
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Linezolid
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action