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Completed

NCT Number: NCT02641041

Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BIIB033 in Healthy Japanese Participants

The primary objective of this study is to assess the safety and tolerability of a single dose and multiple doses of BIIB033 administered to healthy adult Japanese participants. The secondary objectives of this study are to evaluate the pharmacokinetics (PK) profile of BIIB033 administered as single and multiple doses in healthy adult Japanese participants and to assess the single-dose and multiple-dose immunogenicity of BIIB033.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

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

Key Inclusion Criteria:

  • Japanese subjects must have been born in Japan, and their biological parents and grandparents must all have been of Japanese origin.
  • Subjects who have lived out of Japan for more than 5 years must not have significantly modified their diets since leaving Japan.
  • Must be a nonsmoker or light smoker (<10 cigarettes per day) and be willing to abstain from using tobacco and tobacco-containing products during the Inpatient Period and for at least 48 hours prior to Day -1, Day 14 (for Cohort 3), and all outpatient visits.
  • Must have a body mass index of 18 to 32 kg/m2, inclusive.

Key Exclusion Criteria:

  • History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
  • 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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

BIIB033

Biological

single or multiple dose

Placebo

Other

single or multiple dose

Primary outcomes

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

    Time frame: Up to day 113

  2. Number of participants with clinically significant laboratory parameters

    Time frame: Up to day 113

  3. Number of participants with clinically significant vital sign abnormalities

    Time frame: Up to day 113

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

    Time frame: Up to day 113

  5. Number of participants with clinically significant physical examination abnormalities

    Time frame: Up to day 113

  6. Number of participants with clinically significant neurological examination abnormalities

    Time frame: Up to day 113

Secondary outcomes

  1. PK parameter of BIIB033: Area under the concentration-time curve from time zero to infinity (AUCinf)

    Time frame: Up to day 113

  2. PK parameter of BIIB033: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)

    Time frame: Up to day 113

  3. PK parameter of BIIB033: AUC over a given dosing interval

    Time frame: Up to day 113

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

    Time frame: Up to day 113

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

    Time frame: Up to day 113

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

    Time frame: Up to day 113

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

    Time frame: Up to day 113

  8. PK parameter of BIIB033: Clearance (CL)

    Time frame: Up to day 113

  9. PK parameter of BIIB033: accumulation ratio (RAC)

    Time frame: Up to day 113

  10. Number of participants with positive serum BIIB033 antibodies

    Time frame: Up to day 113

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 29, 2015
Registry last updated
Oct 10, 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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