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

• Sponsor: Yuji KUMAGAI (Other)
• Overall Status: Completed
• CT.gov ID: NCT03055403
• Collaborator: Aetas Pharma Co. Ltd. (Industry)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.3
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 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: Feb 17, 2017
• Actual Primary Completion Date: Nov 28, 2017
• Actual Study Completion Date: Nov 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events as a measure of safety and tolerability [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 [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 [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 [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 [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-∞ [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 [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 [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 [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 [up to 24 hours]

   Amount of drug excreted in urine from time zero to 24hour of M201-A

10. Pharmacokinetics-Ae [up to 24 hours]

    Urinary excretion rate of M201-A

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 39 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Trial Center, Kitasato University Hospital, THE KITASATO INSTITUTE	Sagamihara	Kanagawa	Japan	252-0375

Sponsors and Collaborators

• Yuji KUMAGAI
• Aetas Pharma Co. Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuji KUMAGAI, Professor, Kitasato University
• ClinicalTrials.gov Identifier: NCT03055403
• Other Study ID Numbers: M201-A-CT-001
• First Posted: Feb 16, 2017
• Last Update Posted: Nov 30, 2021
• Last Verified: Nov 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Nov 30, 2021