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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-10

Study Completion Date

2019-07-01

Brief Summary

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

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Detailed Description

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

Conditions

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Pulmonary Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

LCB01-0371 800mg, QD

Group Type EXPERIMENTAL

LCB01-0371 800mg, QD

Intervention Type DRUG

Oral administration

Group 2

LCB01-0371 400mg, BID

Group Type EXPERIMENTAL

LCB01-0371 400mg, BID

Intervention Type DRUG

Oral administration

Group 3

LCB01-0371 800mg, BID

Group Type EXPERIMENTAL

LCB01-0371 800mg, BID

Intervention Type DRUG

Oral administration

Group 4

Tubes 3\~5Tablet, QD

Group Type ACTIVE_COMPARATOR

Tubes 3~5Tablet, QD

Intervention Type DRUG

Oral administration

Group 5

Zyvox 600mg, BID

Group Type ACTIVE_COMPARATOR

Zyvox 600mg, BID

Intervention Type DRUG

Oral administration

Group 6

LCB01-0371 1200mg, QD

Group Type EXPERIMENTAL

LCB01-0371 1200mg, QD

Intervention Type DRUG

Oral administration

Interventions

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LCB01-0371 800mg, QD

Oral administration

Intervention Type DRUG

LCB01-0371 400mg, BID

Oral administration

Intervention Type DRUG

LCB01-0371 800mg, BID

Oral administration

Intervention Type DRUG

Tubes 3~5Tablet, QD

Oral administration

Intervention Type DRUG

Zyvox 600mg, BID

Oral administration

Intervention Type DRUG

LCB01-0371 1200mg, QD

Oral administration

Intervention Type DRUG

Other Intervention Names

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LCB01-0371 LCB01-0371 LCB01-0371 Tubes Tablet Zyvox Tablet LCB01-0371

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No