Multiple Dose Escalation Study of M201-A in Healthy Japanese Subjects

  • STATUS
    Recruiting
  • participants needed
    9
  • sponsor
    Kitasato University
Send
Updated on 19 February 2024
See if I qualify
body mass index

Summary

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

Details
Condition Healthy Volunteers
Age 20years - 49years
Treatment Placebo, M201-A Injection
Clinical Study IdentifierNCT04464681
SponsorKitasato University
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects must satisfy the following criteria to be enrolled in the study
(1)Japanese Healthy Male subjects
(2)Age 20 to less than 50 years of age
(3)Body Weight of more than 50 kg, Body Mass Index (BMI) of 18.5 to less than 25.0 kg/m2 at the screening examination
(4)Written informed consent must be obtained on a voluntary basis before any assessment is performed

Exclusion Criteria

The presence of any of the following will exclude a subject from enrollment
(1)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
(2)Past medical history of cancer, cerebral infarction or cardiac infarction
(3)Past history of surgical operation of gastrointestine or kidney except appendectomy or hemorrhoid operation
(4)Presence or past history of epilepsy
(5)Presence or past medical history of allergic reactions or idiosyncrasies to food, medicinal substance and metallic materials
(6)heart rate(HR) >= 100 bpm at the screening examination
(7)The corrected QT interval(QTcF) >= 440 ms at the screening examination
(8)brain natriuretic peptide(BNP) > 40 pg/mL at the screening examination
(9)K<3.6 mEq/L at the screening examination
(10)Past history or suspect of aldosteronism
(11)Any risk factors of Torsades de Pointes including such as heart failure, hypokalemia, long QT interval syndrome due to family medical history
(12)Cre>1.10 mg/dL, <0.85 mg/dL at the screening examination
(13)Subject who donated whole blood of 400 mL within 12 weeks or whole blood of 400 mL of 200 mL / blood component donation within 4weeks prior to the first administration
(14)Use of prescription drug, over-the-counter medications (except eye drops for dryness, sanitizer for preventing infection), or herbal medication within 4 weeks prior to study medication
(15)Subject who consumed furanocoumarin containing food within 7 days prior to study medication
(16)Subject who drunk alcohol or caffeine containing drink within 3 days prior to study medication
(17)Subject who was administered of another investigational drug within16 weeks prior to agree to participate in this study
(18)Subject who was administered M201-A in the past
(19)Subject who smoke within 90 day prior to study medication or who cannot quit smoking during the study period
(20)Subject with positive result in hepatitis B(HB)s antigen, hepatitis C virus(HCV) antibody, HIV antigen/antibody, Syphilis serum, urine drug test at the screening test. Subject with positive result in Coronavirus(COVID-19) test at the screening or at the hospitalization
(21) Presence or past history of drug/alcohol abuse
(22)Subject who do not use medically acceptable contraceptive method until 90 days after the final study drug administration
(23)Subject who investigator judges ineligible for other reasons
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

body mass index

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.