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

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02833142
• Other study ID #: 215HV103
• Status: Completed
• Phase: Phase 1
• First received: July 12, 2016
• Last updated: December 6, 2016
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: December 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Acute Optic Neuritis
• Multiple Sclerosis
• Neuritis
• Optic Neuritis

Intervention

Drug:
• BIIB033 (opicinumab)

Locations

Country	Name	City	State
United States	Research Site	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)		Up to Day 89	No
Primary	PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)		Day 85	No
Primary	PK parameter of BIIB033: Maximum observed concentration (Cmax)		Up to Day 89	No
Secondary	Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 17 weeks	No
Secondary	Number of participants with clinically significant laboratory parameters		Up to 17 weeks	No
Secondary	Number of participants with clinically significant vital sign abnormalities		Up to 17 weeks	No
Secondary	Number of participants with clinically significant electrocardiograms (ECGs) abnormalities		Up to 17 weeks	No
Secondary	Number of participants with clinically significant physical examination abnormalities		Up to 17 weeks	No
Secondary	PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)		Up to Day 89	No
Secondary	PK parameter of BIIB033: Terminal elimination half-life (t1/2)		Up to Day 89	No
Secondary	PK parameter of BIIB033: Volume of distribution at steady state (Vss)		Up to Day 89	No
Secondary	PK parameter of BIIB033: Clearance (CL)		Up to Day 89	No
Secondary	Number of participants with presence of anti-BIIB033 antibodies		Pre-dose, Day 22 and Day 85	No