Safety, tolerability, and how the body processes intravenous ME3241 in healthy adults

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

This trial will test intravenous ME3241 in healthy adults to see if it is safe, well tolerated, and how the body handles the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Meiji Pharma USA Inc. (Industry-sponsored)
• Locations: 1 site (Sydney, New South Wales)
• Trial ID: NCT07422207 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study enrolls healthy adults aged 18–55 to receive intravenous ME3241 or placebo and tracks safety, tolerability, and pharmacokinetics. Participants must meet weight and BMI criteria and complete screening exams including medical history, physical exam, ECG, and laboratory tests. Study staff will monitor vital signs, ECGs, labs, and collect timed blood samples to measure drug concentrations. Individuals with recent serious infections, pneumonia, or significant chronic medical conditions are excluded to reduce risk.

Who should consider this trial

Good fit: Ideal participants are healthy adults 18–55 years old with a BMI of 18.0–30.0 kg/m2, body weight over 45 kg, and no significant medical history or recent serious infections.

Not a fit: People with active or recent serious infections, or with significant autoimmune, cardiac, hepatic, renal, respiratory, neurological, or mental health disorders are excluded and would not be expected to benefit from participation.

Why it matters

Potential benefit: If successful, the study would establish initial safety and dosing information and show how ME3241 is processed in the body, enabling further clinical development.

How similar studies have performed: Early-phase safety and pharmacokinetic studies like this are a standard first step for new drugs and have commonly succeeded in defining dosing and safety parameters, though they do not show therapeutic benefit.

Eligibility criteria

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.

Where this trial is running

Sydney, New South Wales

• Scientia Clinical Reserch Ltd — Sydney, New South Wales, Australia (Recruiting)

Study contacts

• Study coordinator: Meiji Pharma USA Inc. Study Lead

Conditions Healthy Volunteers