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

Phase 1CompletedNCT03905291

Medy-Tox25 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

MT921DRUG

Formulated as an injectable solution

PlaceboDRUG

normal saline

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Anam Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)

Peak plasma concentration measured by Liquid Chromatography-mass spectrometry (LC/MS) achieving in the test area of the body after administration.

Time frame: Up to 24 hours

AUC0-24

Area under the plasma concentration versus time curve from time 0 to 24 hours measured by Liquid Chromatography-mass spectrometry (LC/MS) after administration

Time frame: Up to 24 hours

Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS)

The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS).

Time frame: Up to 24 hours

Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS)

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).

Time frame: Up to 24 hours

Data from ClinicalTrials.gov

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