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First-in-Human Dose Escalation Study of M201-A in Healthy Japanese Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055403
Recruitment Status : Unknown
Verified February 2017 by Yuji KUMAGAI, Kitasato University.
Recruitment status was:  Recruiting
First Posted : February 16, 2017
Last Update Posted : February 20, 2017
Sponsor:
Collaborator:
Aetas Pharma Co., Ltd.
Information provided by (Responsible Party):
Yuji KUMAGAI, Kitasato University

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: M201-A Injection Drug: Placebo Phase 1

Detailed Description:
Not Provided

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single Continuous Intravenous Injection, Dose Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of M201-A in Healthy Japanese Subjects
Actual Study Start Date : February 17, 2017
Estimated Primary Completion Date : August 31, 2017
Estimated Study Completion Date : December 31, 2017

Arm Intervention/treatment
Experimental: M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection
Drug: M201-A Injection
Active Substance: M201-A Route of administration: continuous intravenous injection

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




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Throughout the study duration (up to day8) ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetics-Cmax [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Observed maximum plasma concentration (Cmax) of M201-A

  2. Pharmacokinetics-Tmax [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Time to Cmax (Tmax) of M201-A

  3. Pharmacokinetics-AUC0-24 [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Area under the plasma concentration-time curve from time zero to 24hour of M201-A

  4. Pharmacokinetics-AUC0-t [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    -Area under the plasma concentration-time curve calculated from time zero to the last measured time point (AUC0-t) of M201-A

  5. Pharmacokinetics-AUC0-∞ [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Area under the plasma concentration-time curve calculated from time zero to infinity (AUC0-∞) of M201-A

  6. Pharmacokinetics-t1/2 [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Elimination half-life (t1/2) of M201-A

  7. Pharmacokinetics-CL [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Apparent clearance of drug from plasma (CL) of M201-A

  8. Pharmacokinetics-Vd [ Time Frame: Predose, 0, 5, 15, 30, 60, 120, 240, 480 minutes and 24 hours after the IV infusion of M201-A ]
    Apparent volume of distribution during the terminal phase (Vd) of M201-A

  9. Pharmacokinetics-E0-24 [ Time Frame: up to 24 hours ]
    Amount of drug excreted in urine from time zero to 24hour of M201-A

  10. Pharmacokinetics-Ae [ Time Frame: up to 24 hours ]
    Urinary excretion rate of M201-A



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055403


Contacts
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Contact: Mika Maeda 81-42-778-8111 ext 8242 m-maeda@kitasato-u.ac.jp

Locations
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Japan
Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE Recruiting
Sagamihara, Kanagawa, Japan, 252-0375
Contact: Mika Maeda    81-42-778-8111 ext 8242    m-maeda@kitasato-u.ac.jp   
Contact: Kenji Kobayashi    81-42-778-8111 ext 7845    kobaken@kitasato-u.ac.jp   
Principal Investigator: Yuji Kumagai         
Sub-Investigator: Masako Aso         
Sub-Investigator: Yoshiya Ito         
Sub-Investigator: Hideki Amano         
Sub-Investigator: Yuko Shibata         
Sub-Investigator: Masako Nagashima         
Sub-Investigator: Chie Kurashige         
Sub-Investigator: Tomoyoshi Inoue         
Sub-Investigator: Sakiko Yamane         
Sub-Investigator: Tomohiro Betto         
Sub-Investigator: Junya Ako         
Sub-Investigator: Hidehira Fukaya         
Sub-Investigator: Jun Kishihara         
Sub-Investigator: Akira Satoh         
Sub-Investigator: Naruya Ishizue         
Sub-Investigator: Tamami Fujiishi         
Sub-Investigator: Tazuru Igarashi         
Sub-Investigator: Yuichiro Iida         
Sub-Investigator: Hironori Nakamura         
Sub-Investigator: Teppei Fujita         
Sub-Investigator: Kazuhiro Fujiyoshi         
Sub-Investigator: Toyoji Kaida         
Sub-Investigator: Takuya Hashimoto         
Sub-Investigator: Ryota Kakizaki         
Sub-Investigator: Teruyoshi Nemoto         
Sponsors and Collaborators
Yuji KUMAGAI
Aetas Pharma Co., Ltd.
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Responsible Party: Yuji KUMAGAI, Professor, Kitasato University
ClinicalTrials.gov Identifier: NCT03055403    
Other Study ID Numbers: M201-A-CT-001
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No