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OpenTrials
Completed

NCT Number: NCT03905291

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

Completed

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Key information

Conditions

Healthy Volunteers

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anam Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT921

Drug

Formulated as an injectable solution

Placebo

Drug

normal saline

Primary outcomes

  1. 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.

  2. 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

  3. 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).

  4. 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).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medy-Tox

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2019
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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