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Completed

NCT Number: NCT02833142

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BIIB033 (opicinumab)

Drug

Primary outcomes

  1. PK parameter of BIIB033: Area under the concentration-time curve from time 0 to infinity (AUC0-inf)

    Time frame: Up to Day 89

  2. PK parameter of BIIB033: Area under the concentration-time curve from time 0 to Day 85 (AUC84d)

    Time frame: Day 85

  3. PK parameter of BIIB033: Maximum observed concentration (Cmax)

    Time frame: Up to Day 89

Secondary outcomes

  1. Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to 17 weeks

  2. Number of participants with clinically significant laboratory parameters

    Time frame: Up to 17 weeks

  3. Number of participants with clinically significant vital sign abnormalities

    Time frame: Up to 17 weeks

  4. Number of participants with clinically significant electrocardiograms (ECGs) abnormalities

    Time frame: Up to 17 weeks

  5. Number of participants with clinically significant physical examination abnormalities

    Time frame: Up to 17 weeks

  6. PK parameter of BIIB033: Time to reach maximum observed concentration (Tmax)

    Time frame: Up to Day 89

  7. PK parameter of BIIB033: Terminal elimination half-life (t1/2)

    Time frame: Up to Day 89

  8. PK parameter of BIIB033: Volume of distribution at steady state (Vss)

    Time frame: Up to Day 89

  9. PK parameter of BIIB033: Clearance (CL)

    Time frame: Up to Day 89

  10. Number of participants with presence of anti-BIIB033 antibodies

    Time frame: Pre-dose, Day 22 and Day 85

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2016
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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