NCT03055403

Brief Summary

This Phase I first-in-human is designed to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of M201-A administered by single continuous intravenous injection in Healthy Japanese subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy-volunteers

Timeline
Completed

Started Feb 2017

Typical duration for phase_1 healthy-volunteers

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

First Submitted

Initial submission to the registry

February 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 16, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2017

Completed
Last Updated

November 30, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

February 10, 2017

Last Update Submit

November 28, 2021

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events as a measure of safety and tolerability

    adverse events, serious adverse events, physical examinations, vital sign measurements, 12-lead ECGs, Holter ECG, clinical laboratory safety tests (including hematology, chemistry, and urinalysis), recording of concomitant medications and procedures.

    Throughout the study duration (up to day8)

Secondary Outcomes (10)

  • Pharmacokinetics-Cmax

    Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A

  • Pharmacokinetics-Tmax

    Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A

  • Pharmacokinetics-AUC0-24

    Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A

  • Pharmacokinetics-AUC0-t

    Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A

  • Pharmacokinetics-AUC0-∞

    Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A

  • +5 more secondary outcomes

Study Arms (2)

M201-A Injection

EXPERIMENTAL

Active Substance: M201-A Route of administration: continuous intravenous injection

Drug: M201-A Injection

Placebo

PLACEBO COMPARATOR

Saline Placebo for M201-A Route of administration: continuous intravenous injection

Drug: Placebo

Interventions

M201-A InjectionDRUG

Active Substance: M201-A Route of administration: continuous intravenous injection

M201-A Injection
PlaceboDRUG

Saline Placebo for M201-A Route of administration: continuous intravenous injection

Placebo

Eligibility Criteria

Age20 Years - 39 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must satisfy the following criteria to be enrolled in the study:
  • Japanese Healthy Male subjects
  • Age 20 to less than 40 years of age
  • Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2
  • Written informed consent must be obtained on a voluntary basis before any assessment is performed.

You may not qualify if:

  • The presence of any of the following will exclude a subject from enrollment:
  • Presence or past medical history of hepatic impairments, renal impairments, cardiovascular disease, gastrointestinal disease and others which are inappropriate for participating in this clinical trial
  • Past medical history of cancer, cerebral infarction or cardiac infarction
  • Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
  • QTcF \> 450ms at the screening examination
  • NT-proBNP \> 125 pg/mL at the screening examination
  • Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE

Sagamihara, Kanagawa, 252-0375, Japan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 16, 2017

Study Start

February 17, 2017

Primary Completion

November 28, 2017

Study Completion

November 28, 2017

Last Updated

November 30, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)