NCT03905291

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 5, 2019

Completed
Last Updated

August 25, 2020

Status Verified

August 1, 2020

Enrollment Period

5 months

First QC Date

March 25, 2019

Last Update Submit

August 24, 2020

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Other Outcomes (1)

  • Number of participants with adverse events as assessed by MedDRA version 17.0

    Up to 21 days

Study Arms (4)

MT921 60mg Group

EXPERIMENTAL

MT921 60 mg

Drug: MT921

MT921 120mg Group

EXPERIMENTAL

MT921 120 mg

Drug: MT921

MT921 150mg Group

EXPERIMENTAL

MT921 150 mg

Drug: MT921

Placebo Group

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

MT921DRUG

Formulated as an injectable solution

MT921 120mg GroupMT921 150mg GroupMT921 60mg Group
PlaceboDRUG

normal saline

Placebo Group

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged between 20 and 65 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anam Hospital

Seoul, South Korea

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2019

First Posted

April 5, 2019

Study Start

July 31, 2018

Primary Completion

December 26, 2018

Study Completion

December 26, 2018

Last Updated

August 25, 2020

Record last verified: 2020-08

Locations

KR(1)