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

NCT07422207 | Not Yet Recruiting Phase 1

• 1 other identifier: ME3241-1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (10)

• Incidence and severity of AEs and SAEs

  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

  Evaluation of body temperature, blood pressure, and pulse

  From baseline to 12 weeks after the last administration

• Changes in physical examinations

  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

  Evaluation of PR, QRSd, and QT/QTcF intervals

  From baseline to 12 weeks after the last administration

• Changes in laboratory parameters

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

  From baseline to 12 weeks after the last administration

• Maximum observed serum concentration (Cmax)

  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)

  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-∞)

  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)

  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)

  Evaluation of the apparent terminal elimination half-life

  From baseline to 12 weeks after the last administration

Study Arms (2)

ME3241

EXPERIMENTAL

Biological: ME3241

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

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.

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Meiji Pharma USA Inc.: lead

Study Sites (1)

Scientia Clinical Reserch Ltd

Sydney, New South Wales, 2031, Australia

Location

Central Study Contacts

Meiji Pharma USA Inc. Study Lead

CONTACT

+1 201-777-7133; mpu.contact@meiji.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

AU (1)