A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

March 31, 2026 updated by: Meiji Pharma USA Inc.

A Phase 1, First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

104

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
  • Participant must be in good general health as determined by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests.
  • Participant must have body weight > 45 kg at the Screening Visit.
  • Participant must have a body mass index (BMI) between 18.0 and 30.0 kg/m^2 at the Screening Visit. BMI = body weight (kg)/(height [m])^2.

Exclusion Criteria:

  • Participant with concurrent or history of potentially fatal infections such as opportunistic infections, including sepsis and systemic fungal infection.
  • Participant with history of pulmonary infiltrates or pneumonia within 6 months prior to the Screening Visit.
  • Participant with concurrent or history of autoimmune, cardiac, hepatic, renal, gastrointestinal, respiratory, endocrine, neurological, central nervous, mental disorders, and/or hematological function disorders, which, in the judgment of the investigator, may affect participation in this clinical study.
  • Participant with history and/or presence of malignancy of any organ system (including basal cell carcinoma of the skin), treated or untreated.

Other protocol defined inclusion/exclusion criteria could apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo

Part 1 (single ascending dose):

Participants will receive a single infusion of placebo.

Part 2 (multiple ascending dose):

Participants will receive multiple infusions of placebo.

Part 3 (single dose for Japanese participants):

Japanese participants will receive a single infusion of placebo.
Experimental: ME3241
Biological: ME3241

Part 1 (single ascending dose):

Participants will receive a single infusion of ME3241.

Part 2 (multiple ascending dose):

Participants will receive multiple infusions of ME3241.

Part 3 (single dose for Japanese participants):

Japanese participants will receive a single infusion of ME3241.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of AEs and SAEs
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the number and percentage of participants with AEs, treatment-emergent adverse events (TEAEs), and the number of TEAEs
From baseline to 12 weeks after the last administration
Changes in vital signs
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of body temperature, blood pressure, and pulse
From baseline to 12 weeks after the last administration
Changes in physical examinations
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the number and percentage of participants with normal/non-clinically significant abnormal or clinically significant abnormal results in physical examination
From baseline to 12 weeks after the last administration
Changes in 12-lead ECGs
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of PR, QRSd, and QT/QTcF intervals
From baseline to 12 weeks after the last administration
Changes in laboratory parameters
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters
From baseline to 12 weeks after the last administration
Maximum observed serum concentration (Cmax)
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the maximum observed serum concentration of ME3241
From baseline to 12 weeks after the last administration
Area under the curve from time zero to the last quantifiable concentration (AUClast)
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve from time zero to the last quantifiable concentration
From baseline to 12 weeks after the last administration
Area under the curve from time zero extrapolated to infinity (AUC0-∞)
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve from time zero extrapolated to infinity
From baseline to 12 weeks after the last administration
Area under the curve over the dosing interval after multiple dose administration (AUCtau)
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the area under the curve over the dosing interval after multiple dose administration
From baseline to 12 weeks after the last administration
Apparent terminal elimination half-life (t1/2)
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of the apparent terminal elimination half-life
From baseline to 12 weeks after the last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meiji Pharma USA Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ME3241-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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