Healthy Volunteers
Conditions
Brief summary
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of ME3241 Administered Intravenously in Healthy Adult Participants
Interventions
BIOLOGICALME3241
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.
OTHERPlacebo
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.
Sponsors
Meiji Pharma USA Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of AEs and SAEs | 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 | From baseline to 12 weeks after the last administration | Evaluation of body temperature, blood pressure, and pulse |
| Changes in physical examinations | 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 12-lead ECGs | From baseline to 12 weeks after the last administration | Evaluation of PR, QRSd, and QT/QTcF intervals |
| Changes in laboratory parameters | From baseline to 12 weeks after the last administration | Evaluation of Hematology, Clinical chemistry, Coagulation, and Urinalysis parameters |
| Maximum observed serum concentration (Cmax) | 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) | 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-∞) | 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) | 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) | From baseline to 12 weeks after the last administration | Evaluation of the apparent terminal elimination half-life |
Countries
Australia
Contacts
CONTACTMeiji Pharma USA Inc. Study Lead
Outcome results
None listed