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Multiple Ascending Dose Study for LCB01-0371

This study has been completed.
Information provided by (Responsible Party):
LegoChem Biosciences, Inc Identifier:
First received: April 20, 2013
Last updated: November 14, 2014
Last verified: November 2014


  • To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose
  • To investigate the pharmacokinetic characteristics of LCB01-0371 after a multiple oral dose in healthy male subjects
  • To investigate the safety of LCB01-0371 after a multiple oral dose in healthy male subjects

Condition Intervention Phase
Drug: LCB01-0371 800mg
Drug: LCB01-0371 1200mg
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Study, Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability, and Population Pharmacokinetics of LCB01-0371 in Healthy Male Subjects.

Further study details as provided by LegoChem Biosciences, Inc:

Primary Outcome Measures:
  • Number of participants with adverse events [ Time Frame: Up to 7 days ]

Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of LCB01-0371 [ Time Frame: Up to 7 days ]
  • Peak Plasma Concentration (Cmax) of LCB01-0371 [ Time Frame: Up to 7 days ]

Enrollment: 30
Study Start Date: March 2013
Study Completion Date: December 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LCB01-0371 800mg
LCB01-0371 800mg
Drug: LCB01-0371 800mg
LCB0-0371 800mg
Other Name: LCB0-0371 800mg
Experimental: LCB01-0371 1200mg
LCB01-0371 1200mg
Drug: LCB01-0371 1200mg
LCB01-0371 1200mg
Placebo Comparator: Placebo
Drug: Placebo

Detailed Description:
  • To investigate the PK characteristics of LCB01-0371 after a multiple oral dose
  • To investigate the safety and tolerability of LCB01-0371 after a multiple oral dose

Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Health Male between 20 and 45 years of age at the time of screening and a subject with body mass index (BMI) between 19 and 27
  2. Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
  3. Able to donate blood during study period and follow visit.
  4. Agree to continue to use a reliable method of birth control until 60 days after study completion.
  5. Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Exclusion Criteria:

  1. History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
  2. History of gastrointestinal problem which is affect to absorption within 6 months from screening
  3. History of hypersensitivity or clinically significant adverse drug reaction(s) to the LCB01-0371, same class of the study drugs (linezolid), or other drugs including aspirin and antibiotics.
  4. History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01842516

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
LegoChem Biosciences, Inc
Principal Investigator: Kyun-Seop Bae, MD, PhD. Asan Medical Center
  More Information

Responsible Party: LegoChem Biosciences, Inc Identifier: NCT01842516     History of Changes
Other Study ID Numbers: LCB01-0371-12-1-02
Study First Received: April 20, 2013
Last Updated: November 14, 2014 processed this record on May 24, 2017