The primary objective is to determine the safety and tolerability of single and multiple ascending subcutaneous (SC) doses and a single intravenous (IV) dose of BIIB107 in healthy adult participants. The secondary objectives are to characterize the single-dose pharmacokinetic (PK) of SC and IV BIIB107 in healthy adult participants and to characterize the multiple-dose PK of SC BIIB107 in healthy adult participants.
BIIB107 is a monoclonal antibody (mAb) that targets alpha-4 integrins and is currently in development for people with multiple sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
CenExel Anaheim Clinical Trials
Anaheim, California, United States
QPS MRA (Miami Research Associates)
Miami, Florida, United States
Altasciences Clinical Research
Overland Park, Kansas, United States
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Single Ascending Dose (SAD)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
Time frame: Day -1 up to Day 84
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs): Multiple Ascending Dose (MAD)
An AE is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, places the participant at immediate risk of death, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is a medically important event.
Time frame: Day -1 up to Day 169
Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
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Maximum Observed Concentration (Cmax): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Time to Reach Maximum Observed Concentration (Tmax): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Terminal Half-Life (t1/2): SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Clearance (CL) for IV Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Apparent Clearance (CL/F) of SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Volume of Distribution at Steady State (Vss) for IV Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Bioavailability (F) of SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Absorption Rate Profile of SC Doses: SAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 84
Maximum Observed Concentration (Cmax): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Time to Reach Maximum Observed Concentration (Tmax): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Area Under the Concentration-Time Curve Over the Dosing Interval (AUCtau): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Trough Concentration (Ctrough): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Terminal Half-Life (t1/2): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Accumulation Ratio (R): MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Apparent Clearance (CL/F) of SC Doses: MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169
Apparent Volume of Distribution During the Terminal Elimination Phase (Vz/F) for SC Doses: MAD
Time frame: Day 1 pre-dose and multiple time-points up to Day 169