Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01407406




Registration number
NCT01407406
Ethics application status
Date submitted
14/07/2011
Date registered
2/08/2011
Date last updated
16/09/2013

Titles & IDs
Public title
Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers
Scientific title
A Single-Dose, Randomized, Double-Blind, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers
Secondary ID [1] 0 0
211HV102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BIIB023 - low dose IV Dose
Treatment: Drugs - BIIB023 - high dose IV Dose

Experimental: Chinese Subjects - low dose BIIB023 IV -

Experimental: Chinese Subjects - high dose BIIB023 IV -

Experimental: Japanese Subjects - low dose BIIB023 IV -

Experimental: Japanese Subjects - high dose BIIB023 IV -

Experimental: Causasian Subjects - low dose BIIB023 IV -

Experimental: Caucasian Subjects - high dose BIIB023 IV -


Treatment: Drugs: BIIB023 - low dose IV Dose


Treatment: Drugs: BIIB023 - high dose IV Dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC of BIIB023
Timepoint [1] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Primary outcome [2] 0 0
Cmax of BIIB023
Timepoint [2] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Primary outcome [3] 0 0
Tmax of BIIIB023
Timepoint [3] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Primary outcome [4] 0 0
Half-life of BIIB023
Timepoint [4] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Primary outcome [5] 0 0
Volume of distribution of BIIB023
Timepoint [5] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Primary outcome [6] 0 0
Clearance of BIIB023
Timepoint [6] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Secondary outcome [1] 0 0
Number of patients with Adverse Events as a measure of safety and tolerability
Timepoint [1] 0 0
Participants will be followed for the duration of a study; an expected 71 days
Secondary outcome [2] 0 0
Number of patients with Serious Adverse Events as a measure of safety and tolerability
Timepoint [2] 0 0
Participants will be followed for the duration of a study; an expected 71 days

Eligibility
Key inclusion criteria
- Must have the ability to understand the purpose and risks of the study & provide
signed & dated informed consent.

- Chinese, Japanese or Caucasian subjects

- Subjects of childbearing potential must practice effective contraception during the
study and 3 months after their last dose of study treatment.

- Must have a BMI within the range of 18.5 to 25 kg/m2.

- Must be willing to abstain from using tobacco and tobacco-containing products during
the in-clinic period.

- Must be willing to limit alcohol intake to no more than 2 units per day throughout the
duration of the study (with some stricter exceptions at various timepoints).

- Must be deemed healthy as determined by the Investigator, based on assessments at
Screening and Day -1.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Known to have a positive test result for Human Immunodeficiency Virus (HIV) antibody.

- Known history of hepatitis C or hepatitis B virus.

- History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test.

- Subjects with a history of carcinoma in situ and malignant disease. (with the
exception of basal cell carcinoma that has been completely excised prior to study)

- History of clinically important severe allergic or anaphylactic reactions.

- Known allergy to components of the BIIB023 formulation.

- History of any clinically important cardiac, endocrinologic, hematologic, hepatic,
immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric,
and renal, or other major disease, as determined by the Investigator.

- Abnormal hematology or blood chemistry values at Screening or Day -1, as determined by
the Investigator.

- Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to
Screening.

- History of drug or alcohol abuse (as defined by the Investigator) within 6 months
prior to screening, and/or a positive urine drug screen (without a medically indicated
rationale) or positive alcohol breath test at Screening or on Day -1.

- Active bacterial or viral infection and fever >38°C within 48 hours prior to study
treatment administration.

- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive
during the study.

- Surgery within 3 months prior to Day -1 or any surgical procedure planned during the
course of the study

- Previous exposure to BIIB023.

- Treatment with another investigational drug , device, or approved therapy for
investigational use within 30 days prior to Day -1, or 7 half lives of the
investigational product, whichever is longer

- Treatment with any prescription medication within 2 weeks before Day -1 with the
exception of oral contraceptives for women of childbearing potential.

- Treatment with any nonprescription medicinal products (including
vitamin/mineral/herbal containing preparations but excluding acetaminophen) within the
7 days prior to study treatment.

- Vaccination within 4 weeks of study treatment.

- Blood donation (1 unit or more) within 1 month prior to study treatment or plasma
donation within 7 days prior to study treatment.

- Alcohol use within 48 hours prior to study treatment or during the In-Clinic period.

- Current enrollment in any other study treatment or disease study.

- Inability to comply with study requirements.

- Vigorous exercise (as determined by the Investigator) within 72 hours prior to any
study visit.

- Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec,
make the subject unsuitable for enrollment.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2012
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Rationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese
populations to support future clinical development of BIIB023 in China and Japan.

Study Design: This is a single-dose study to assess the PK, safety, and tolerability of
BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy
volunteers. The Caucasian group is included to allow comparison of PK data from different
groups using data from the same study under the same controlled conditions.

Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up
to 100 days.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01407406
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01407406