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NCT03905291 Clinical Trial

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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03905291
Other study ID # MT11-KR17SMF115
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 31, 2018
Est. completion date December 26, 2018

Study information
Verified date August 2020
Source Medy-Tox
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date December 26, 2018
Est. primary completion date December 26, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 65 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• MT921
Formulated as an injectable solution
• Placebo
normal saline

Locations
Country Name City State
Korea, Republic of Anam Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Medy-Tox

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of participants with adverse events as assessed by MedDRA version 17.0 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
Primary 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. Up to 24 hours
Primary 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 Up to 24 hours
Primary 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). Up to 24 hours
Primary 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). Up to 24 hours
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