Healthy Volunteers
Conditions
Brief summary
To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects
Interventions
DRUGMT921
Formulated as an injectable solution
DRUGPlacebo
normal saline
Sponsors
Medy-Tox
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Concentration (Cmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) | 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. |
| AUC0-24 | 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 |
| Maximum Time (Tmax) measured by Liquid Chromatography-mass spectrometry (LC/MS) | Up to 24 hours | The time at which the Cmax is observed measured by Liquid Chromatography-mass spectrometry (LC/MS). |
| Half-life (t1/2) measured by Liquid Chromatography-mass spectrometry (LC/MS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as assessed by MedDRA version 17.0 | 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. |
Countries
South Korea
Outcome results
None listed