Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects

August 24, 2020 updated by: Medy-Tox

A Randomized, Double-blinded, Placebo-controlled, Single Center, Dose Escalation, Phase I Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects

To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged between 20 and 65 years

Exclusion Criteria:

  • Subject not appropriate for participating in this study according to the investigator's opinion

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MT921 60mg Group
MT921 60 mg
Drug: MT921
Formulated as an injectable solution
Experimental: MT921 120mg Group
MT921 120 mg
Drug: MT921
Formulated as an injectable solution
Experimental: MT921 150mg Group
MT921 150 mg
Drug: MT921
Formulated as an injectable solution
Placebo Comparator: Placebo Group
Placebo
Drug: Placebo
normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
Time Frame: Up to 24 hours
Peak plasma concentration measured by Liquid Chromatography-mass spectrometry (LC/MS) achieving in the test area of the body after administration.
Up to 24 hours
AUC0-24
Time Frame: Up to 24 hours
Area under the plasma concentration versus time curve from time 0 to 24 hours measured by Liquid Chromatography-mass spectrometry (LC/MS) after administration
Up to 24 hours
Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)
Time Frame: Up to 24 hours
The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS).
Up to 24 hours
Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS)
Time Frame: Up to 24 hours
The time it takes for the concentration of the drug in the plasma or the total amount in the body to be reduced by 50% measured by Liquid Chromatography-mass spectrometry (LC/MS).
Up to 24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events as assessed by MedDRA version 17.0
Time Frame: Up to 21 days
Assessment of safety in investigational product with the number of participants with adverse events as assessed by MedDRA version 17.0.
Up to 21 days

Collaborators and Investigators

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

Sponsor

Medy-Tox

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)

July 31, 2018

Primary Completion (Actual)

December 26, 2018

Study Completion (Actual)

December 26, 2018

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 4, 2019

First Posted (Actual)

April 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 24, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • MT11-KR17SMF115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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