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

Phase 1RecruitingNCT07422207

Meiji Pharma USA Inc.104 enrolled

Overview

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

104

Conditions

Healthy Volunteers

Interventions

ME3241BIOLOGICAL

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.

PlaceboOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Scientia Clinical Reserch Ltd

Sydney, New South Wales, Australia

RECRUITING

Outcomes

Primary Outcomes

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