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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME3241 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Meiji Pharma USA Inc. Study Lead | Contact | +1 201-777-7133 | mpu.clinical@meiji.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientia Clinical Reserch Ltd | Recruiting | Sydney | New South Wales | 2031 | Australia |
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| 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. |
|
| 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 |