Multiple Ascending Dose, Phase 1 Clinical Study of LCB01-0371

September 1, 2015 updated by: LegoChem Biosciences, Inc

A Phase I Clinical Study, Multiple Dose of LCB01-0371 in Healthy Male Subjects

The purpose of this study is to investigate the population pharmacokinetics of LCB01-0371 after a multiple oral dose in healthy male subjects.

To investigate safety, tolerability of LCB01-0371 after a multiple oral dose in healthy male subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Double blind, randomized, placebo control, multiple dose, dose escalation study

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Bundang, Gyeonggi, Korea, Republic of
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy male between 20 and 45 years of age at the time of screening
  2. Subjects with body mass index (BMI) between 20 kg/m2 and 27 kg/m2 at the time of screening
  3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 30th days after study completion
  4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements.

Exclusion Criteria:

  1. History of liver, kidney, alimentary, respiratory, musculoskeletal, endocrine, neuropsychiatric, hemato-oncologic, cardiovascular problem(s)
  2. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) within 6 months possibly affecting absorption of clinical trial drugs, or history of surgery (except simple appendectomy and herniotomy)
  3. History of hypersensitivity reaction or history of clinically significant hypersensitivity reaction to LCB01-0371 or same class of the study drugs (linezolid) or other drugs including aspirin and antibiotics
  4. History of drug abuse or positive result at urine drug screening
  5. AST, ALT, r-GT, bilirubin(total) values over than 1.5 times of ULN

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCB01-0371 800mg
Drug: Placebo
Placebo
Drug: LCB01-0371 800mg
LCB01-0371 800mg
Experimental: LCB01-0371 800mg BID
Drug: Placebo
Placebo
Drug: LCB01-0371 800mg BID
LCB01-0371 800mg BID
Experimental: LCB01-0371 1200mg BID
Drug: Placebo
Placebo
Drug: LCB01-0371 1200mg BID
LCB01-0371 1200mg BID
Placebo Comparator: Placebo
LCB01-0371 800mg, LCB01-0371 800mg BID, LCB01-0371 1200mg BID
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
No of Adverse events
Time Frame: From date of randomization until follow up after 3 days from last hospital discharge
From date of randomization until follow up after 3 days from last hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics: Cmax(Peak plasma concentration)
Time Frame: 0(predose), 0.5, 1, 2, 4, 8 and 12hours
Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days
0(predose), 0.5, 1, 2, 4, 8 and 12hours
Pharmacokinetics: AUC(Area under the curve)
Time Frame: 0(predose), 0.5, 1, 2, 4, 8 and 12hours
Predose date: 1, 3, 6, 9, 12, 15, 17, 19, 20 and 21Days
0(predose), 0.5, 1, 2, 4, 8 and 12hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LegoChem Biosciences, Inc

Investigators

  • Study Director: Young Lag Cho, Ph.D., Legochembioscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

November 13, 2014

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 4, 2015

Last Update Submitted That Met QC Criteria

September 1, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCB01-0371-14-1-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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