Overview

This trial is active, not recruiting.

Conditions multiple sclerosis, acute optic neuritis
Treatment biib033 (opicinumab)
Phase phase 1
Sponsor Biogen
Start date July 2016
End date November 2016
Trial size 28 participants
Trial identifier NCT02833142, 215HV103

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
Arm
(Experimental)
Staggered single dosing schema
biib033 (opicinumab)
(Experimental)
Staggered single dosing schema
biib033 (opicinumab)

Primary Outcomes

Measure
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 Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Biogen.