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A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects

NCT ID: NCT03809039

Last Updated: 2025-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-15

Study Completion Date

2020-07-01

Brief Summary

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The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Single Ascending Dose: MT-6345 & Placebo

Group Type EXPERIMENTAL

MT-6345

Intervention Type DRUG

MT-6345

MT-6345 Placebo

Intervention Type DRUG

MT-6345 Placebo

Multiple Ascending Dose: MT-6345 & Placebo

Group Type EXPERIMENTAL

MT-6345

Intervention Type DRUG

MT-6345

MT-6345 Placebo

Intervention Type DRUG

MT-6345 Placebo

Interventions

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MT-6345

MT-6345

Intervention Type DRUG

MT-6345 Placebo

MT-6345 Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Additional screening criteria check may apply for qualification:

* Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
* Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening and Day -1.
* A body weight of ≥60 kg for males and ≥50 kg for females and a body mass index (BMI) (Quetelet index) ranging from 18 to 30.0 kg/m2 inclusive at Screening and Day -1.
* In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.

Exclusion Criteria

Additional screening criteria check may apply for qualification:

* Subjects with clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological, renal, cardiovascular disease, or history (within the last 5 years) of any significant psychiatric/psychotic illness disorder (including anxiety, depression and reactive depression).
* Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or lactating.
* Having previously received MT-6345 as part of this study.
* Clinically relevant abnormal medical history, physical findings or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
* Subjects who test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanabe Pharma America, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Head of Medical Science,

Role: STUDY_DIRECTOR

Tanabe Pharma America, Inc.

Locations

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Investigational center

City Name, , United Kingdom

Site Status

Countries

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United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2018-002478-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MT-6345-E01

Identifier Type: -

Identifier Source: org_study_id