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Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02833142
First Posted: July 14, 2016
Last Update Posted: December 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Biogen
  Purpose
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.

Condition Intervention Phase
Multiple Sclerosis Acute Optic Neuritis Drug: BIIB033 (opicinumab) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Biogen:

Primary Outcome Measures:
  • PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) [ Time Frame: Up to Day 89 ]
  • PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d) [ Time Frame: Day 85 ]
  • PK parameter of BIIB033: Maximum observed concentration (Cmax) [ Time Frame: Up to Day 89 ]

Secondary Outcome Measures:
  • Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 17 weeks ]
  • Number of participants with clinically significant laboratory parameters [ Time Frame: Up to 17 weeks ]
  • Number of participants with clinically significant vital sign abnormalities [ Time Frame: Up to 17 weeks ]
  • Number of participants with clinically significant electrocardiograms (ECGs) abnormalities [ Time Frame: Up to 17 weeks ]
  • Number of participants with clinically significant physical examination abnormalities [ Time Frame: Up to 17 weeks ]
  • PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax) [ Time Frame: Up to Day 89 ]
  • PK parameter of BIIB033: Terminal elimination half-life (t1/2) [ Time Frame: Up to Day 89 ]
  • PK parameter of BIIB033: Volume of distribution at steady state (Vss) [ Time Frame: Up to Day 89 ]
  • PK parameter of BIIB033: Clearance (CL) [ Time Frame: Up to Day 89 ]
  • Number of participants with presence of anti-BIIB033 antibodies [ Time Frame: Pre-dose, Day 22 and Day 85 ]

Enrollment: 28
Study Start Date: July 2016
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BIIB033-A
Staggered single dosing schema
Drug: BIIB033 (opicinumab)
Experimental: BIIB033-B
Staggered single dosing schema
Drug: BIIB033 (opicinumab)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02833142


Locations
United States, Wisconsin
Research Site
Madison, Wisconsin, United States, 53704
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen
  More Information

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02833142     History of Changes
Other Study ID Numbers: 215HV103
First Submitted: July 12, 2016
First Posted: July 14, 2016
Last Update Posted: December 8, 2016
Last Verified: December 2016

Keywords provided by Biogen:
Healthy Volunteer
opicinumab

Additional relevant MeSH terms:
Multiple Sclerosis
Neuritis
Optic Neuritis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases