Daclizumab Japanese PK Study

NCT01929746 | Completed Phase 1

• 2 other identifiers: 205HV102EUDRA CT NO: 2013-002310-12
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to evaluate the pharmacokinetic (PK) profile of BIIB019 (Daclizumab High Yield Process; DAC HYP) administered as a single subcutaneous (SC) dose (75 mg or 150 mg) Japanese and Caucasian adult healthy volunteers. The secondary objective of this study in this study population is to assess the safety and tolerability of BIIB019 administered as a single SC dose (75 mg or 150 mg).

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Area under the concentration-time curve from time 0 to infinity (AUCinf)

  Up to Day 105

• Maximum observed concentration (Cmax)

  Up to Day 105

• Time to reach maximum observed concentration (Tmax)

  Up to Day 105

• Terminal elimination half-life (t1/2)

  Up to Day 105

• Apparent volume of distribution (Vd/F)

  Up to Day 105

• Apparent clearance (CL/F)

  Up to Day 105

Secondary Outcomes (1)

• The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to Day 105

Study Arms (2)

BIIB019, 75 mg

EXPERIMENTAL

BIIB019 delivered via Subcutaneous Injection

Biological: BIIB019 subcutaneous injection

BIIB019, 150 mg

EXPERIMENTAL

BIIB019 delivered via Subcutaneous Injection

Biological: BIIB019 subcutaneous injection

Interventions

BIIB019 subcutaneous injection BIOLOGICAL

participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group

Also known as: Daclizumab High Yield Process, DAC HYP

BIIB019, 150 mg; BIIB019, 75 mg

Eligibility Criteria

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

You may qualify if:

• Japanese subjects must have been born in Japan, have both parents and grandparents of Japanese origin, and not have lived outside of Japan for more than 5 years or significantly modified their diets since leaving Japan.
• Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 4 months after their last dose of study treatment.
• Body mass index (BMI) within 18 to 30 kg/m2, inclusive.
• Nonsmoker or be willing to abstain from using tobacco and tobacco-containing products for 24 hours prior to clinic admission and during the In-Clinic Period and to smoke no more than 10 cigarettes per day throughout the remainder of the study.
• Must be willing to refrain from all alcohol consumption for 48 hours prior to Day 1 and during the In-Clinic Period and to limit the intake of alcohol to no more than 2 units per day throughout the remainder of the study.

You may not qualify if:

• History of a positive test result for human immunodeficiency virus (HIV) antibody.
• History of hepatitis or a positive test result for hepatitis C virus antibody (HCVAb) or hepatitis B virus antibody (test for hepatitis B surface antigen \[HBsAg\] and/or hepatitis B core antibody \[HBcAb\]).
• History of tuberculosis (TB) or a positive QuantiFERON®-TB Gold test. There must be no other clinical evidence of TB on physical examination of the subject. Note: Subjects who have had prior adequate prophylaxis treatment for latent TB with an appropriate course of isoniazid or equivalent, per country standards, are not excluded from study participation.
• 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, are not eligible.
• 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.

Sponsors & Collaborators

• Biogen: lead
• AbbVie: collaborator

Study Sites (1)

Research Site

Leeds, United Kingdom

Location

MeSH Terms

Interventions

daclizumab HYP

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2013
• First Posted: August 28, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 2, 2014

Record last verified: 2014-05

Locations

GB (1)