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

LigaChem Biosciences

Status and phase: Completed; Phase 2

Conditions: Pulmonary Tuberculosis

Treatments: Drug: LCB01-0371 800mg, QD; Drug: LCB01-0371 800mg, BID; Drug: Tubes 3~5Tablet, QD; Drug: LCB01-0371 1200mg, QD; Drug: LCB01-0371 400mg, BID; Drug: Zyvox 600mg, BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02836483

LCB01-0371-15-2-01

Details and patient eligibility

About

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

Full description

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

Enrollment: 79 patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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79 participants in 6 patient groups

Group 1

Experimental group

Description:

LCB01-0371 800mg, QD

Treatment:

Drug: LCB01-0371 800mg, QD

Group 2

Experimental group

Description:

LCB01-0371 400mg, BID

Treatment:

Drug: LCB01-0371 400mg, BID

Group 3

Experimental group

Description:

LCB01-0371 800mg, BID

Treatment:

Drug: LCB01-0371 800mg, BID

Group 4

Active Comparator group

Description:

Tubes 3\~5Tablet, QD

Treatment:

Drug: Tubes 3~5Tablet, QD

Group 5

Active Comparator group

Description:

Zyvox 600mg, BID

Treatment:

Drug: Zyvox 600mg, BID

Group 6

Experimental group

Description:

LCB01-0371 1200mg, QD

Treatment:

Drug: LCB01-0371 1200mg, QD