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IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers

NCT02882789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-04-10

No results posted yet for this study

Summary

Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary

• To investigate the absolute bio availability of LCB01-0371 after a single intravenous dose

Conditions

  • Healthy

Interventions

DRUG

LCB01-0371

Cohort1 \& 3: Placebo-controlled, Single ascending dose administration

DRUG

LCB01-0371 400mg

Cohort 2: Crossover designed administration

Sponsors & Collaborators

  • LigaChem Biosciences, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
39 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02882789 on ClinicalTrials.gov