Phase 1, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of multiple doses of BION-1301 in Japanese healthy subjects.
This is a Phase 1 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody. This is a single-center, open-label study designed to evaluate safety, tolerability, pharmacokinetic, and pharmacodynamic of a single subcutaneous dose of BION-1301 in Japanese healthy subjects in 3 dose level cohorts. The study will enroll up to 36 Japanese subjects across 3 dose level cohorts.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
A solution for SC injection administered as a single dose
Collaborative Neuroscience Research, LLC
Long Beach, California, United States
Safety and tolerability of BION-1301
Number of subjects with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs); changes from baseline in safety parameters; and number of subjects with injection site reactions
Time frame: Day 85
Pharmacokinetics-Cmax
Maximum plasma concentration
Time frame: Day 85
Pharmacokinetics-Tmax
Time at which the maximum plasma concentration (Cmax) occurs
Time frame: Day 85
Pharmacokinetics-AUC∞
Area under the plasma concentration-time curve from dosing (time zero) extrapolated to infinity
Time frame: Day 85
Pharmacokinetics-AUClast
Area under the plasma concentration-time curve from dosing (time zero) to the time of the last measured concentration
Time frame: Day 85
Pharmacokinetics-t1/2
Time required for the drug concentration to decrease by a factor of one-half in the terminal phase
Time frame: Day 85
Pharmacokinetics-CL/F
Serum concentration after single dose will be measured and the apparent oral clearance will be calculated
Time frame: Day 85
Pharmacokinetics-Vz/F
Serum concentration after single dose will be measured and the apparent volume of distribution will be calculated
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Time frame: Day 85
The effect of BION-1301 on pharmacodynamic (PD) parameters
Changes in immunoglobulin levels (IgA, IgG, and IgM)
Time frame: Day 85
The levels of anti-drug antibodies
Blood anti-drug antibodies (ADA) and neutralizing antibody (NAb) levels
Time frame: Day 85