Daclizumab Japanese PK Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

NCT06243198

Healthy

COMPLETED PHASE1

A Study of LY3463251 in Healthy Participants

NCT03764774

Healthy

TERMINATED PHASE1

Study of IFN-K in Dermatomyositis

NCT02980198

Dermatomyositis

WITHDRAWN PHASE2

A Study of DS-1211b in Individuals With PseudoXanthoma Elasticum

NCT05569252

Pseudoxanthoma Elasticum

COMPLETED PHASE2

Safety and Tolerability of XmAb®7195 in Adult Healthy Volunteers and Adult Subjects With a History of Allergic Rhinitis and/or Allergic Conjunctivitis and/or Atopic Dermatitis

NCT02148744

Allergic Rhinitis Allergic Conjunctivitis Atopic Dermatitis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BIIB019, 75 mg

BIIB019 delivered via Subcutaneous Injection

Group Type EXPERIMENTAL

BIIB019 subcutaneous injection

Intervention Type BIOLOGICAL

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

BIIB019, 150 mg

BIIB019 delivered via Subcutaneous Injection

Group Type EXPERIMENTAL

BIIB019 subcutaneous injection

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BIIB019 subcutaneous injection

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

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Daclizumab High Yield Process DAC HYP

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes