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

• ClinicalTrials.gov Identifier: NCT02836483
• Recruitment Status: Completed
• First Posted: July 19, 2016
• Last Update Posted: February 6, 2020
• Sponsor: LegoChem Biosciences, Inc
• Information provided by (Responsible Party): LegoChem Biosciences, Inc

Tracking Information

• First Submitted Date: July 5, 2016
• First Posted Date: July 19, 2016
• Last Update Posted Date: February 6, 2020
• Actual Study Start Date: December 10, 2016
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 28, 2017)

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

• Original Primary Outcome Measures (submitted: July 18, 2016): The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15 [ Time Frame: V2(Baseline), V9(Day 15) ]

Current Secondary Outcome Measures (submitted: August 28, 2017)

• 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

Original Secondary Outcome Measures (submitted: July 18, 2016)

• The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3 [ Time Frame: V2(Baseline), V4(Day 3) ]
• The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 15 [ Time Frame: V4(Day 2), V9(Day 15) ]
• The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8 [ Time Frame: V4(Day 2), V6(Day 8) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK
• 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
• Brief Summary: A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.
• Detailed Description: This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pulmonary Tuberculosis

Intervention

• Drug: LCB01-0371 800mg, QD
  Oral administration
  Other Name: LCB01-0371
• Drug: LCB01-0371 400mg, BID
  Oral administration
  Other Name: LCB01-0371
• Drug: LCB01-0371 800mg, BID
  Oral administration
  Other Name: LCB01-0371
• Drug: Tubes 3~5Tablet, QD
  Oral administration
  Other Name: Tubes Tablet
• Drug: Zyvox 600mg, BID
  Oral administration
  Other Name: Zyvox Tablet
• Drug: LCB01-0371 1200mg, QD
  Oral administration
  Other Name: LCB01-0371

Study Arms

• Experimental: Group 1
  LCB01-0371 800mg, QD
  Intervention: Drug: LCB01-0371 800mg, QD
• Experimental: Group 2
  LCB01-0371 400mg, BID
  Intervention: Drug: LCB01-0371 400mg, BID
• Experimental: Group 3
  LCB01-0371 800mg, BID
  Intervention: Drug: LCB01-0371 800mg, BID
• Active Comparator: Group 4
  Tubes 3~5Tablet, QD
  Intervention: Drug: Tubes 3~5Tablet, QD
• Active Comparator: Group 5
  Zyvox 600mg, BID
  Intervention: Drug: Zyvox 600mg, BID
• Experimental: Group 6
  LCB01-0371 1200mg, QD
  Intervention: Drug: LCB01-0371 1200mg, QD

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 4, 2020): 79
• Original Estimated Enrollment (submitted: July 18, 2016): 30
• Actual Study Completion Date: July 1, 2019
• Actual Primary Completion Date: July 1, 2019 (Final data collection date for primary outcome measure)

Eligibility 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 75 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT02836483
• Other Study ID Numbers: LCB01-0371-15-2-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: LegoChem Biosciences, Inc
• Study Sponsor: LegoChem Biosciences, Inc
• Collaborators: Not Provided

Investigators

• Principal Investigator: T.S Sim, M.D., Ph.D; Asan Medical Center

• PRS Account: LegoChem Biosciences, Inc
• Verification Date: February 2020