Single Ascending Doses of BIIB063 in Healthy Volunteers

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02555085
• Other study ID #: 234HV101
• Secondary ID: 2015-001283-18
• Status: Terminated
• Phase: Phase 1
• First received: August 27, 2015
• Last updated: April 17, 2017
• Start date: September 30, 2015
• Est. completion date: June 1, 2016

Study information

• Verified date: April 2017
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: June 1, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• BIIB063
Single ascending IV dose

Other:
• Placebo
Single dose

Locations

Country	Name	City	State
United Kingdom	Research Site	Leeds	West Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to week 12
Primary	Number of participants with clinically significant laboratory assessment abnormalities		Up to week 12
Primary	Number of participants with clinically significant Vital sign abnormalities		Up to week 12
Primary	Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities		Up to week 12
Primary	Number of participants with clinically significant physical examination abnormalities		Up to week 12
Primary	Change in antibody titers of vaccine immunization for tetanus		Up to week 12
Primary	Change in antibody titers of vaccine immunization for diphtheria		Up to week 12
Primary	Change in antibody titers of vaccine immunization for pneumococcus		Up to week 12
Secondary	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
Secondary	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
Secondary	PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)		Up to week 12
Secondary	PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)		Up to week 12
Secondary	PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)		Up to week 12
Secondary	PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)		Up to week 12
Secondary	PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)		Up to week 12
Secondary	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
Secondary	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
Secondary	PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)		Up to week 12
Secondary	PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)		Up to week 12
Secondary	PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)		Up to week 12
Secondary	PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)		Up to week 12
Secondary	PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)		Up to week 12
Secondary	PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)		Up to week 12
Secondary	Number of participants with positive serum anti-BIIB063 antibodies		Up to week 12
Secondary	Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063		Up to 12 weeks