Single Ascending Doses of BIIB063 in Healthy Volunteers

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: Terminated
• Conditions: Healthy
• Intervention / Treatment: Biological: BIIB063; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)	Up to week 12
Number of participants with clinically significant laboratory assessment abnormalities	Up to week 12
Number of participants with clinically significant Vital sign abnormalities	Up to week 12
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities	Up to week 12
Number of participants with clinically significant physical examination abnormalities	Up to week 12
Change in antibody titers of vaccine immunization for tetanus	Up to week 12
Change in antibody titers of vaccine immunization for diphtheria	Up to week 12
Change in antibody titers of vaccine immunization for pneumococcus	Up to week 12

Secondary Outcome Measures

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)	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)	Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)	Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)	Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)	Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)	Up to week 12
PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)	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)	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)	Up to week 12
PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)	Up to week 12
PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)	Up to week 12
PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)	Up to week 12
PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)	Up to week 12
PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)	Up to week 12
PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)	Up to week 12
Number of participants with positive serum anti-BIIB063 antibodies	Up to week 12
Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063	Up to 12 weeks

Collaborators and Investigators

• Sponsor: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2015
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 21, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 234HV101; 2015-001283-18 (EudraCT Number)