Single Ascending Doses of BIIB063 in Healthy Volunteers

April 17, 2017 updated by: Biogen

Phase 1 Randomized, Blinded, Placebo-Controlled Study of Single Ascending Doses of BIIB063 in Healthy Volunteers

The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers. The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LD2 9LH
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • All male subjects and all female subjects of childbearing potential must practice at least 1 highly effective method of contraception (i.e., contraceptive measure with a failure rate of <1% per year; estrogen-containing contraceptives are prohibited) during the study and be willing and able to continue contraception for 4 months after being dosed with study treatment. Male subjects must also be willing to refrain from sperm donation for at least 4 months after the last dose of study treatment. Male subjects must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study.
  • Must have a body mass index between 18 and 30 kg/m2, inclusive.
  • Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.

Key Exclusion Criteria:

  • History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
  • 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.
  • Personal or family history of cardiovascular disease under the age of 50 years, inherited disorder of coagulation (e.g., Factor V Leiden, protein C or S deficiency), or anti-phospholipid Ab syndrome (APS).
  • History of meningococcal vaccination or meningococcal meningitis, or history of hypersensitivity to single components of meningococcal vaccines (including MENVEO), any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine.
  • History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test
  • Personal history of thromboembolic events
  • Treatment with any prescription or over-the-counter medication within 14 days prior to randomization (excluding vitamins, dietary supplements, herbal preparations, progestin-only birth control, and paracetamol up to 4 g/day for no more than 5 consecutive days).
  • Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months
  • Current enrollment or a plan to enroll in any other drug, biologic or device clinical study, or treatment with an investigational drug or approved therapy for investigational use within 3 months
  • Blood donation (1 unit or more) within 3 months prior to randomization.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IV Dose 1
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: IV Dose 2
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: IV Dose 3
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: IV Dose 4
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: IV Dose 5
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: IV Dose 6
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: IV Dose 7
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose
Experimental: SC Dose
Single SC dose or matching placebo
Biological: BIIB063
Single ascending IV dose
Other: Placebo
Single dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to week 12
Up to week 12
Number of participants with clinically significant laboratory assessment abnormalities
Time Frame: Up to week 12
Up to week 12
Number of participants with clinically significant Vital sign abnormalities
Time Frame: Up to week 12
Up to week 12
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time Frame: Up to week 12
Up to week 12
Number of participants with clinically significant physical examination abnormalities
Time Frame: Up to week 12
Up to week 12
Change in antibody titers of vaccine immunization for tetanus
Time Frame: Up to week 12
Up to week 12
Change in antibody titers of vaccine immunization for diphtheria
Time Frame: Up to week 12
Up to week 12
Change in antibody titers of vaccine immunization for pneumococcus
Time Frame: Up to week 12
Up to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Time Frame: Up to week 12
Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time Frame: Up to week 12
Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)
Time Frame: Up to week 12
Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)
Time Frame: Up to week 12
Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)
Time Frame: Up to week 12
Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)
Time Frame: Up to week 12
Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)
Time Frame: Up to week 12
Up to week 12
PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)
Time Frame: Up to week 12
Up to week 12
Number of participants with positive serum anti-BIIB063 antibodies
Time Frame: Up to week 12
Up to week 12
Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063
Time Frame: Up to 12 weeks
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 21, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 18, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 234HV101
  • 2015-001283-18 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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