Multiple Ascending Dose Study for LCB01-0371

LigaChem Biosciences

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LCB01-0371 800mg; Drug: Placebo; Drug: LCB01-0371 1200mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01842516

LCB01-0371-12-1-02

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

LCB01-0371 800mg

Experimental group

Description:

LCB01-0371 800mg

Treatment:

Drug: LCB01-0371 800mg

LCB01-0371 1200mg

Experimental group

Description:

LCB01-0371 1200mg

Treatment:

Drug: LCB01-0371 1200mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo