This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Otilimab will be administered via pre-filled syringe.
Maximum drug concentration (Cmax) following administration of otilimab
Time frame: Up to 8 Weeks
Area under the concentration-time curve from pre-dose to infinity (AUC[0-infinity]) following administration of otilimab
Time frame: Up to 8 Weeks
Area under the plasma concentration-time curve from pre-dose to t (AUC[0-t]) following administration of otilimab
Time frame: Up to 8 Weeks
Time to maximum plasma concentration (Tmax) following administration of otilimab
Time frame: Up to 8 Weeks
Elimination half-life (t1/2) following administration of otilimab
Time frame: Up to 8 Weeks
Time to reach the last quantifiable plasma concentration (Tlast) following administration of otilimab
Time frame: Up to 8 Weeks
Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interests (AESIs)
Time frame: Up to 8 weeks
Change from Baseline in hematology parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils and Platelet count (Giga cells per liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Red blood cell (RBC) count (Trillion cells per liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Hemoglobin (Grams per Liter)
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Time frame: Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Hematocrit (Proportion of red blood cells in blood)
Time frame: Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Mean Corpuscular Volume (MCV) (Femtoliters)
Time frame: Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Mean corpuscular hemoglobin (MCH) (Picograms)
Time frame: Baseline and up to 8 weeks
Change from Baseline in hematology parameter: Percentage of reticulocytes (Percentage of reticulocytes)
Time frame: Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Alanine aminotransferase (ALT), Alkaline phosphatase (ALP), Aspartate aminotransferase (AST), Creatine kinase, Gamma Glutamyl transferase (GGT), Lactate Dehydrogenase (International units per Liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Calcium, glucose, potassium, sodium, Chloride, Phosphate and Blood urea nitrogen (BUN) (Millimoles per Liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Creatinine, direct bilirubin, total bilirubin and uric acid (Micromoles per liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameters: Albumin and Total protein (Grams per liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameter: C-reactive protein (CRP) (Milligrams per liter
Time frame: Baseline and up to 8 weeks
Change from Baseline in clinical chemistry parameter: Amylase (Units per liter)
Time frame: Baseline and up to 8 weeks
Change from Baseline in lipid panel parameters: Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol and triglycerides (Millimoles per Liter)
Time frame: Baseline and up to 8 weeks
Number of participants with abnormal urinalysis parameters by Dipstick Method
Time frame: Baseline and up to 8 weeks
Change from Baseline in vital signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury)
Time frame: Baseline and up to 8 weeks
Change from Baseline in vital sign: Pulse rate (Beats per minute)
Time frame: Baseline and up to 8 weeks
Change from Baseline in vital signs: Body temperature (Degrees Celsius)
Time frame: Baseline and up to 8 weeks
Change from Baseline in Electrocardiogram (ECG) parameters: PR interval, QRS duration, QT interval and corrected QT (QTc) interval (Milliseconds)
Time frame: Baseline and up to 8 weeks
Number of participants with anti-drug antibodies (ADAs) to otilimab
Time frame: Up to Week 8
Number of participants with drug-neutralizing antibodies to otilimab
Time frame: Up to Week 8