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NCT Number: NCT07422207

A Study to Investigate 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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scientia Clinical Reserch Ltd

Sydney, New South Wales, 2031, Australia

Location status: Recruiting

Location contact

Dr Christopher Argent

CONTACT

[email protected]

+61 2 9382 5800

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ME3241

Biological

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.

Placebo

Other

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.

Primary outcomes

  1. 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

  2. Changes in vital signs

    Time frame: From baseline to 12 weeks after the last administration

    Evaluation of body temperature, blood pressure, and pulse

  3. 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

  4. Changes in 12-lead ECGs

    Time frame: From baseline to 12 weeks after the last administration

    Evaluation of PR, QRSd, and QT/QTcF intervals

  5. Changes in laboratory parameters

    Time frame: From baseline to 12 weeks after the last administration

    Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Meiji Pharma USA Inc. Study Lead

CONTACT

[email protected]

+1 201-777-7133

Sponsors and collaborators

Lead sponsor

Meiji Pharma USA Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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