Clinical trial NCT02555085: Single Ascending Doses of BIIB063 in Healthy Volunteers
Official title: Phase 1 Randomized, Blinded, Placebo-Controlled Study of Single Ascending Doses of BIIB063 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-09-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers. The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063.


Eligibility criteria: Key Inclusion Criteria:

* All male subjects and all female subjects of childbearing potential must practice at least 1 highly effective method of contraception (i.e., contraceptive measure with a failure rate of \<1% per year; estrogen-containing contraceptives are prohibited) during the study and be willing and able to continue contraception for 4 months after being dosed with study treatment. Male subjects must also be willing to refrain from sperm donation for at least 4 months after the last dose of study treatment. Male subjects must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study.
* Must have a body mass index between 18 and 30 kg/m2, inclusive.
* Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.

Key Exclusion Criteria:

* History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
* Personal or family history of cardiovascular disease under the age of 50 years, inherited disorder of coagulation (e.g., Factor V Leiden, protein C or S deficiency), or anti-phospholipid Ab syndrome (APS).
* History of meningococcal vaccination or meningococcal meningitis, or history of hypersensitivity to single components of meningococcal vaccines (including MENVEO), any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine.
* History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test
* Personal history of thromboembolic events
* Treatment with any prescription or over-the-counter medication within 14 days prior to randomization (excluding vitamins, dietary supplements, herbal preparations, progestin-only birth control, and paracetamol up to 4 g/day for no more than 5 consecutive days).
* Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months
* Current enrollment or a plan to enroll in any other drug, biologic or device clinical study, or treatment with an investigational drug or approved therapy for investigational use within 3 months
* Blood donation (1 unit or more) within 3 months prior to randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to week 12
measure: Number of participants with clinically significant laboratory assessment abnormalities
timeFrame: Up to week 12
measure: Number of participants with clinically significant Vital sign abnormalities
timeFrame: Up to week 12
measure: Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
timeFrame: Up to week 12
measure: Number of participants with clinically significant physical examination abnormalities
timeFrame: Up to week 12
measure: Change in antibody titers of vaccine immunization for tetanus
timeFrame: Up to week 12
measure: Change in antibody titers of vaccine immunization for diphtheria
timeFrame: Up to week 12
measure: Change in antibody titers of vaccine immunization for pneumococcus
timeFrame: Up to week 12
Secondary outcomes:
measure: PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
timeFrame: Up to week 12
measure: PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Up to week 12
measure: PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)
timeFrame: Up to week 12
measure: PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)
timeFrame: Up to week 12
measure: PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)
timeFrame: Up to week 12
measure: PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)
timeFrame: Up to week 12
measure: PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)
timeFrame: Up to week 12
measure: PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)
timeFrame: Up to week 12
measure: Number of participants with positive serum anti-BIIB063 antibodies
timeFrame: Up to week 12
measure: Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Research Site
state: West Yorkshire
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: