Single Ascending Doses of BIIB063 in Healthy Volunteers
Status and phase
Terminated
Phase 1
Conditions
Healthy
Treatments
Other: Placebo
Biological: BIIB063
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Enrollment
29 patients
Sex
All
Ages
18 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
29 participants in 8 patient groups
IV Dose 1
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
IV Dose 2
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
IV Dose 3
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
IV Dose 4
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
IV Dose 5
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
IV Dose 6
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
IV Dose 7
Experimental group
Description:
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Treatment:
Other: Placebo
Biological: BIIB063
SC Dose
Experimental group
Description:
Single SC dose or matching placebo
Treatment:
Other: Placebo
Biological: BIIB063
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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