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Completed

NCT Number: NCT02836483

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

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

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Key information

Conditions

Pulmonary Tuberculosis Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Lung Diseases Mycobacterium Infections Respiratory Tract Diseases Respiratory Tract Infections Tuberculosis Tuberculosis, Pulmonary

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Asan Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LCB01-0371 800mg, QD

Drug

Oral administration

Other names: LCB01-0371

LCB01-0371 400mg, BID

Drug

Oral administration

Other names: LCB01-0371

LCB01-0371 800mg, BID

Drug

Oral administration

Other names: LCB01-0371

Tubes 3~5Tablet, QD

Drug

Oral administration

Other names: Tubes Tablet

Zyvox 600mg, BID

Drug

Oral administration

Other names: Zyvox Tablet

LCB01-0371 1200mg, QD

Drug

Oral administration

Other names: LCB01-0371

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

LigaChem Biosciences, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jul 19, 2016
Registry last updated
Feb 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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