Single Ascending Doses of BIIB063 in Healthy Volunteers

NCT02555085 | Terminated Phase 1

• 2 other identifiers: 234HV1012015-001283-18
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (17)

• 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

Study Arms (8)

IV Dose 1

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

IV Dose 2

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

IV Dose 3

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

IV Dose 4

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

IV Dose 5

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

IV Dose 6

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

IV Dose 7

EXPERIMENTAL

Single ascending IV dose or matching placebo based on body weight recorded on Day 1

Biological: BIIB063; Other: Placebo

SC Dose

EXPERIMENTAL

Single SC dose or matching placebo

Biological: BIIB063; Other: Placebo

Interventions

BIIB063 BIOLOGICAL

Single ascending IV dose

IV Dose 1; IV Dose 2; IV Dose 3; IV Dose 4; IV Dose 5; IV Dose 6; IV Dose 7; SC Dose

Placebo OTHER

Single dose

IV Dose 1; IV Dose 2; IV Dose 3; IV Dose 4; IV Dose 5; IV Dose 6; IV Dose 7; SC Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Leeds, West Yorkshire, LD2 9LH, United Kingdom

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 21, 2015
• Study Start: September 30, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

GB (1)