Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes
Primary Purpose
Multiple Sclerosis, Acute Optic Neuritis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BIIB033 (opicinumab)
Sponsored by
About this trial
This is an interventional basic science trial for Multiple Sclerosis focused on measuring Healthy Volunteer, opicinumab
Eligibility Criteria
Key Inclusion Criteria:
- - Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- - Must have a body mass index of 18 to 32 kg/m2, inclusive.
- - All male participants and all female participants of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for 6 months after being dosed with study treatment. Male participants must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study. Male participants must also be willing to refrain from sperm donation for at least 6 months after dosing with study treatment.
- - Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.
Key Exclusion Criteria:
- - History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease, as determined by the Investigator.
- - History of or ongoing malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Day -1).
- - Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within the 3 months prior to Day -1.
- - Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
- - History of severe allergic or anaphylactic reactions, or history of any allergic reaction that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- - Prior exposure to BIIB033.
- - Female participants who are breastfeeding or pregnant at Screening or Day -1, or plan to become pregnant during the study or during the 6 months following study drug administration.
- - History of, or positive test result at Screening for, human immunodeficiency virus.
- - History of, or positive test result at Screening for, hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody).
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
BIIB033-A
BIIB033-B
Arm Description
Staggered single dosing schema
Staggered single dosing schema
Outcomes
Primary Outcome Measures
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)
PK parameter of BIIB033: Maximum observed concentration (Cmax)
Secondary Outcome Measures
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with clinically significant laboratory parameters
Number of participants with clinically significant vital sign abnormalities
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Number of participants with clinically significant physical examination abnormalities
PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
PK parameter of BIIB033: Terminal elimination half-life (t1/2)
PK parameter of BIIB033: Volume of distribution at steady state (Vss)
PK parameter of BIIB033: Clearance (CL)
Number of participants with presence of anti-BIIB033 antibodies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02833142
Brief Title
Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes
Official Title
A Randomized, Blinded, Parallel-Group, Phase 1 Study of Pharmacokinetics, Safety and Tolerability of Single Intravenous Doses of BIIB033 (Opicinumab ) Produced by 2 Manufacturing Processes, in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of the study is to characterize the pharmacokinetics (PK) of BIIB033-B and to compare the PK profile with that of BIIB033-A in healthy volunteers. Secondary objectives are: To assess the safety and tolerability of BIIB033-A and BIIB033-B; To assess the secondary PK parameters of BIIB033-A and BIIB033-B; To assess the immunogenicity of BIIB033-A and BIIB033-B.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Acute Optic Neuritis
Keywords
Healthy Volunteer, opicinumab
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BIIB033-A
Arm Type
Experimental
Arm Description
Staggered single dosing schema
Arm Title
BIIB033-B
Arm Type
Experimental
Arm Description
Staggered single dosing schema
Intervention Type
Drug
Intervention Name(s)
BIIB033 (opicinumab)
Primary Outcome Measure Information:
Title
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time Frame
Up to Day 89
Title
PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)
Time Frame
Day 85
Title
PK parameter of BIIB033: Maximum observed concentration (Cmax)
Time Frame
Up to Day 89
Secondary Outcome Measure Information:
Title
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 17 weeks
Title
Number of participants with clinically significant laboratory parameters
Time Frame
Up to 17 weeks
Title
Number of participants with clinically significant vital sign abnormalities
Time Frame
Up to 17 weeks
Title
Number of participants with clinically significant electrocardiograms (ECGs) abnormalities
Time Frame
Up to 17 weeks
Title
Number of participants with clinically significant physical examination abnormalities
Time Frame
Up to 17 weeks
Title
PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)
Time Frame
Up to Day 89
Title
PK parameter of BIIB033: Terminal elimination half-life (t1/2)
Time Frame
Up to Day 89
Title
PK parameter of BIIB033: Volume of distribution at steady state (Vss)
Time Frame
Up to Day 89
Title
PK parameter of BIIB033: Clearance (CL)
Time Frame
Up to Day 89
Title
Number of participants with presence of anti-BIIB033 antibodies
Time Frame
Pre-dose, Day 22 and Day 85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- Must have a body mass index of 18 to 32 kg/m2, inclusive.
- All male participants and all female participants of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for 6 months after being dosed with study treatment. Male participants must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study. Male participants must also be willing to refrain from sperm donation for at least 6 months after dosing with study treatment.
- Must be in good health as determined by the Investigator (or designee), based on medical history and screening evaluations.
Key Exclusion Criteria:
- History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease, as determined by the Investigator.
- History of or ongoing malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to Day -1).
- Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator, within the 3 months prior to Day -1.
- Fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to Day -1.
- History of severe allergic or anaphylactic reactions, or history of any allergic reaction that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
- Prior exposure to BIIB033.
- Female participants who are breastfeeding or pregnant at Screening or Day -1, or plan to become pregnant during the study or during the 6 months following study drug administration.
- History of, or positive test result at Screening for, human immunodeficiency virus.
- History of, or positive test result at Screening for, hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen or hepatitis B core antibody).
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes
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