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

NCT02833142 | Completed Phase 1

• 1 other identifier: 215HV103
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Acute Optic Neuritis

Keywords

Healthy Volunteer; opicinumab

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

Study Arms (2)

BIIB033-A

EXPERIMENTAL

Staggered single dosing schema

Drug: BIIB033 (opicinumab)

BIIB033-B

EXPERIMENTAL

Staggered single dosing schema

Drug: BIIB033 (opicinumab)

Interventions

BIIB033 (opicinumab) DRUG

BIIB033-A; BIIB033-B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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).

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

opicinumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 8, 2016

Record last verified: 2016-12

Locations

US (1)