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

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Acute Optic Neuritis
• Intervention / Treatment: Drug: BIIB033 (opicinumab)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BIIB033-A; Staggered single dosing schema	Drug: BIIB033 (opicinumab)
EXPERIMENTAL: BIIB033-B; Staggered single dosing schema	Drug: BIIB033 (opicinumab)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ACTUAL): November 1, 2016
• Study Completion (ACTUAL): November 1, 2016

Study Registration Dates

• First Submitted: July 12, 2016
• First Submitted That Met QC Criteria: July 13, 2016
• First Posted (ESTIMATE): July 14, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): December 8, 2016
• Last Update Submitted That Met QC Criteria: December 6, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Healthy Volunteer; opicinumab
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Eye Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Multiple Sclerosis; Neuritis; Optic Neuritis
• Other Study ID Numbers: 215HV103