ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 8 for:    biib033

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02641041
Recruitment Status : Completed
First Posted : December 29, 2015
Last Update Posted : October 10, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Central Nervous System (CNS) Demyelinating Disease Multiple Sclerosis Biological: BIIB033 Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Blinded, Placebo-Controlled, Single- and Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Healthy Japanese Subjects
Study Start Date : February 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1
Biological: BIIB033
single or multiple dose

Other: Placebo
single or multiple dose

Experimental: Cohort 2
A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1
Biological: BIIB033
single or multiple dose

Other: Placebo
single or multiple dose

Experimental: Cohort 3
One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15
Biological: BIIB033
single or multiple dose

Other: Placebo
single or multiple dose




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641041


Locations
United Kingdom
Research Site
Leeds, West Yorkshire, United Kingdom, LS2 9LH
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02641041     History of Changes
Other Study ID Numbers: 215HV102
2015-004560-11 ( EudraCT Number )
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by Biogen:
Japanese
Single Ascending Dose (SAD)
Multiple Ascending Dose (MAD)

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Diseases
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases