The primary objective of the study is to evaluate the safety and tolerability of single-ascending intravenous (IV) infusions of BIIB076 in healthy volunteers and participants with Alzheimer's disease (AD). A secondary objective of the study for both healthy volunteers and participants with AD is to assess the serum pharmacokinetic(s) (PK) profile of BIIB076 after single-dose administration. Another secondary objective is to evaluate the immunogenicity of BIIB076 in serum after single-dose administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
46
MD Clinical
Hallandale, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety surveillance
Time frame: Baseline up to Week 20
BIIB076 serum pharmacokinetics (PK) concentration levels
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
PK parameter of BIIB076: Area under the concentration-time curve from time zero to infinity (AUCinf)
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
PK parameter of BIIB076: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
PK parameter of BIIB076: Maximum observed concentration (Cmax)
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
PK parameter of BIIB076: Time to reach maximum observed concentration (Tmax)
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
PK parameter of BIIB076: Terminal elimination half-life (t1/2)
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
PK parameter of BIIB076: Clearance (CL)
Assessment of BIIB076 pharmacokinetics in blood
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Indiana University
Indianapolis, Indiana, United States
St Louis Clinical Trial
St Louis, Missouri, United States
Covance Dallas CRU
Dallas, Texas, United States
Covance CRU
Madison, Wisconsin, United States
Time frame: Up to Week 20
PK parameter of BIIB076: Volume of distribution (Vd)
Assessment of BIIB076 pharmacokinetics in blood
Time frame: Up to Week 20
Number of participants with positive serum BIIB076 antibodies
Serological assessment (of anti-BIIB076 antibodies in blood)
Time frame: Up to Week 20