Status:
COMPLETED
Multiple Ascending Dose Study for LCB01-0371
Lead Sponsor:
LigaChem Biosciences, Inc.
Conditions:
Healthy
Eligibility:
All Genders
20-45 years
Phase:
PHASE1
Brief Summary
Primary * 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 ...
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
Eligibility Criteria
Inclusion
- 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
- Medically healthy with no clinically significant screening results through Physical examination, x-ray, 12 lead ECG, Laboratory test
- Able to donate blood during study period and follow visit.
- Agree to continue to use a reliable method of birth control until 60 days after study completion.
- Capable of giving written informed consent and Able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.
Exclusion
- History of liver, kidney, respiratory, musculoskeletal, endocrinologic, neuropsychiatric, hemato-oncologic, or cardiovascular problem(s).
- History of gastrointestinal problem which is affect to absorption within 6 months from screening
- 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.
- History drug abuse or positive result of urine drug screening test for amphetamine, methamphetamine, barbiturate, cocaine, opiate, benzodiazepine, cannabinoid, methadone, etc.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01842516
Start Date
March 1 2013
End Date
December 1 2013
Last Update
November 17 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea