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Daclizumab Japanese PK Study

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ClinicalTrials.gov Identifier: NCT01929746
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : May 2, 2014
Sponsor:
Collaborator:
AbbVie
Information provided by (Responsible Party):
Biogen

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).

Condition or disease Intervention/treatment Phase
Healthy Biological: BIIB019 subcutaneous injection Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Single-Dose, Single-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BIIB019, Daclizumab High Yield Process (DAC HYP), in Japanese and Caucasian Adult Healthy Volunteers
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Daclizumab

Arm Intervention/treatment
Experimental: BIIB019, 75 mg
BIIB019 delivered via Subcutaneous Injection
Biological: BIIB019 subcutaneous injection
participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group
Other Names:
  • Daclizumab High Yield Process
  • DAC HYP

Experimental: BIIB019, 150 mg
BIIB019 delivered via Subcutaneous Injection
Biological: BIIB019 subcutaneous injection
participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group
Other Names:
  • Daclizumab High Yield Process
  • DAC HYP




Primary Outcome Measures :
  1. Area under the concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: Up to Day 105 ]
  2. Maximum observed concentration (Cmax) [ Time Frame: Up to Day 105 ]
  3. Time to reach maximum observed concentration (Tmax) [ Time Frame: Up to Day 105 ]
  4. Terminal elimination half-life (t1/2) [ Time Frame: Up to Day 105 ]
  5. Apparent volume of distribution (Vd/F) [ Time Frame: Up to Day 105 ]
  6. Apparent clearance (CL/F) [ Time Frame: Up to Day 105 ]

Secondary Outcome Measures :
  1. The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 105 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929746


Locations
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United Kingdom
Research Site
Leeds, United Kingdom
Sponsors and Collaborators
Biogen
AbbVie
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01929746    
Other Study ID Numbers: 205HV102
EUDRA CT NO: 2013-002310-12
First Posted: August 28, 2013    Key Record Dates
Last Update Posted: May 2, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Daclizumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs