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
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Meiji Pharma USA Inc.
- Enrollment
- 104
- Locations
- 1
- Primary Endpoint
- Changes in 12-lead ECGs
Study Overview
Brief Summary
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
ME3241
Intervention: ME3241 (Biological)
Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Changes in 12-lead ECGs
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of PR, QRSd, and QT/QTcF intervals
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
Changes in vital signs
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of body temperature, blood pressure, and pulse
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
Changes in laboratory parameters
Time Frame: From baseline to 12 weeks after the last administration
Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters
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
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
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
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
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
Secondary Outcomes
No secondary outcomes reported