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

Sponsor
LegoChem Biosciences, Inc (Industry)
Overall Status
Completed
CT.gov ID
NCT02836483
Collaborator
(none)
79
1
6
30.7
2.6

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
  • 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

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

Study Type:
Interventional
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 :
Dec 10, 2016
Actual Primary Completion Date :
Jul 1, 2019
Actual Study Completion Date :
Jul 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group 1

LCB01-0371 800mg, QD

Drug: LCB01-0371 800mg, QD
Oral administration
Other Names:
  • LCB01-0371
  • Experimental: Group 2

    LCB01-0371 400mg, BID

    Drug: LCB01-0371 400mg, BID
    Oral administration
    Other Names:
  • LCB01-0371
  • Experimental: Group 3

    LCB01-0371 800mg, BID

    Drug: LCB01-0371 800mg, BID
    Oral administration
    Other Names:
  • LCB01-0371
  • Active Comparator: Group 4

    Tubes 3~5Tablet, QD

    Drug: Tubes 3~5Tablet, QD
    Oral administration
    Other Names:
  • Tubes Tablet
  • Active Comparator: Group 5

    Zyvox 600mg, BID

    Drug: Zyvox 600mg, BID
    Oral administration
    Other Names:
  • Zyvox Tablet
  • Experimental: Group 6

    LCB01-0371 1200mg, QD

    Drug: LCB01-0371 1200mg, QD
    Oral administration
    Other Names:
  • LCB01-0371
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    Ages Eligible for Study:
    19 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    LegoChem Biosciences, Inc
    ClinicalTrials.gov Identifier:
    NCT02836483
    Other Study ID Numbers:
    • LCB01-0371-15-2-01
    First Posted:
    Jul 19, 2016
    Last Update Posted:
    Feb 6, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 6, 2020