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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 to Evaluate the EBA, Safety and PK of Orally Administered LCB01-0371 in Adult Patients With Smear-positive Pulmonary Tuberculosis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02836483
Enrollment
79
Registered
2016-07-19
Start date
2016-12-10
Completion date
2019-07-01
Last updated
2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGTubes 3~5Tablet, QD

Oral administration

DRUGZyvox 600mg, BID

Oral administration

DRUGLCB01-0371 1200mg, QD

Oral administration

DRUGLCB01-0371 800mg, QD

Oral administration

DRUGLCB01-0371 400mg, BID

Oral administration

DRUGLCB01-0371 800mg, BID

Oral administration

Sponsors

LigaChem Biosciences, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
EBA0-14V2(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

MeasureTime frameDescription
EBA0-2V2(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
EBA2-14V4(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
EBA2-7V4(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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026