The primary objective of this study is to demonstrate equivalence of the pharmacokinetic (PK) profile of MSB11022 administered by either an auto-injector (AI) or a pre-filled syringe (PFS) as single subcutaneous (s.c.) injection of 40 mg.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
216
Single dose, as a solution, administered subcutaneously, using an auto-injector.
Single dose, as a solution, administered subcutaneously, using a pre-filled syringe.
PRA Health Sciences (PRA) - Early Development Services (EDS)
Lenexa, Kansas, United States
PRA-EDS
Salt Lake City, Utah, United States
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-inf) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Maximum Observed Plasma Concentration (Cmax) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Time to Reach the Maximum Plasma Concentration (Tmax) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Terminal Rate Constant (λz) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Terminal Half-life (t1/2) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Apparent Total Clearance (CL/F) for MSB11022
Time frame: Pre-dose (-1 hour), 4, 8, 12, 24, 48, 72, 96, 120,144,168, 192, 240, 336, 504, 672, 840,1008, 1344 and 1680 hours post-dose
Number of Participants with at Least One Treatment-Emergent Adverse Event (TEAE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment AE. A TEAE is an AE that occurs only once treatment has started.
Time frame: Day 1 (post-dose) to Day 71
Number of Participants with at Least One Serious Adverse Event (SAE)
An SAE is defined as an AE occurring during any study phase that fulfills one or more of the following criteria: * Results in death. * Requires hospitalization (in-patient treatment) or prolongation of existing hospitalization. * Is life-threatening. * Results in persistent or significant disability or incapacity. * Is a congenital anomaly or birth defect. * Is otherwise considered to be medically important.
Time frame: Screening (up to 28 days prior to study admission) to Day 71
Number of Participants with at Least One Adverse Event of Special Interest (AESI)
An AESI is defined as a hypersensitivity reaction of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or above.
Time frame: Screening (up to 28 days prior to study admission) to Day 71
Number of Participants with an Injection Site Reaction (ISR)
Local tolerability will be assessed be evaluating the site of administration. The investigator or designee will check for the presence of injection site reactions, including, erythema, rash, tenderness, swelling, itching, bruising, or other abnormalities.
Time frame: Day 1 (post-dose) to Day 71
Number of Participants who Experience a Clinically Significant Change in Vital Sign Results
Vital sign measurements will include Systolic and diastolic blood pressure, pulse, body temperature and respiratory rate.
Time frame: Screening (up to 28 days prior to study admission) to Day 71
Number of Participants who Experience a Clinically Significant Change in Clinical Laboratory Results
Parameters will include clinical chemistry, coagulation, hematology, urinalysis and serology.
Time frame: Screening (up to 28 days prior to study admission) to Day 71
Number of Participants who Experience a Clinically Significant Change in Electrocardiogram (ECG) Results
A standard 12-lead ECG will be used.
Time frame: Screening (up to 28 days prior to study admission) to Day 71
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