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

NCT ID: NCT03905291

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-31

Study Completion Date

2018-12-26

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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MT921 60mg Group

MT921 60 mg

Group Type EXPERIMENTAL

MT921

Intervention Type DRUG

Formulated as an injectable solution

MT921 120mg Group

MT921 120 mg

Group Type EXPERIMENTAL

MT921

Intervention Type DRUG

Formulated as an injectable solution

MT921 150mg Group

MT921 150 mg

Group Type EXPERIMENTAL

MT921

Intervention Type DRUG

Formulated as an injectable solution

Placebo Group

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

normal saline

Interventions

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MT921

Formulated as an injectable solution

Intervention Type DRUG

Placebo

normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medy-Tox

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anam Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MT11-KR17SMF115

Identifier Type: -

Identifier Source: org_study_id

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