Multiple Ascending Dose Study for LCB01-0371

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01842516

Enrollment

Registered

2013-04-29

Start date

2013-03-31

Completion date

2013-12-31

Last updated

2014-11-17

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

Conditions

Healthy

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

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

Interventions

DRUGLCB01-0371 800mg

LCB0-0371 800mg

DRUGLCB01-0371 1200mg

LCB01-0371 1200mg

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	Up to 7 days

Secondary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC) of LCB01-0371	Up to 7 days
Peak Plasma Concentration (Cmax) of LCB01-0371	Up to 7 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026