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

April 9, 2018 updated by: LegoChem Biosciences, Inc

A Randomized, Single Blind, Single Dose, Phase I Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous Dosage Form of LCB01-0371 in Healthy Male Volunteers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 39 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Healthy Male between 19 and 39 years of age at the time of screening
  2. Subjects with body mass index (BMI) between 19 and 27 at the time of screening
  3. Agree to continue to use a medically reliable dual contraception and not to donate sperm until 28 days of study completion
  4. Capable of giving written informed consent, willing to participate in this clinical trial, and willing to comply with all study requirements

Exclusion Criteria:

  1. History of gastrointestinal problem (e.g. Crohn's disease, gastro-intestinal ulcer) which is affect to absorption OR surgical history except appendectomy, herniotomy
  2. History of allergy, cardiovascular, peripheral vascular, skin, mucous membrane, eyes, otorhinolaryngologic, respiratory, musculoskeletal, infectious disease, gastroenterologic, liver, billiary, endocrinologic, kidney, genitourinary, neuropsychiatric, hemato-oncologic problem(s) or fracture etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LCB01-0371 200mg
LCB01-0371 IV 200 mg
Drug: LCB01-0371
Cohort1 & 3: Placebo-controlled, Single ascending dose administration
Other Names:
  • LCB01-0371 or placebo
Experimental: LCB01-0371 400mg
LCB01-0371 IV 400 mg
Drug: LCB01-0371
Cohort1 & 3: Placebo-controlled, Single ascending dose administration
Other Names:
  • LCB01-0371 or placebo
Drug: LCB01-0371 400mg
Cohort 2: Crossover designed administration
Other Names:
  • LCB01-0371 400mg 2 tablet
Experimental: LCB01-0371 800mg
LCB01-0371 IV 800 mg
Drug: LCB01-0371
Cohort1 & 3: Placebo-controlled, Single ascending dose administration
Other Names:
  • LCB01-0371 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess Peak Plasma Concentration(Cmax) of LCB01-0371
Time Frame: through study completion per patient, an average of 8 days (+ - 1 D)
through study completion per patient, an average of 8 days (+ - 1 D)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LegoChem Biosciences, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 24, 2016

First Posted (Estimate)

August 30, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2018

Last Update Submitted That Met QC Criteria

April 9, 2018

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCB01-0371-16-1-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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