Absolute Bioavailability of Reslizumab in Healthy Subjects

NCT01990443 | Completed Phase 1

• 1 other identifier: C38072/1107
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the absolute bioavailability of reslizumab following administration of a single subcutaneous (sc) dose to healthy non-Japanese participants

Conditions

Absolute Bioavailability

Keywords

Reslizumab; monoclonal antibody

Outcome Measures

Primary Outcomes (1)

• Absolute bioavailability

  Absolute bioavailability calculated as (AUC0-∞)sc/(AUC0-∞)

  From baseline to Day 140

Secondary Outcomes (13)

• Maximum observed serum drug concentration (Cmax)

  From baseline to Day 140

• Time to maximum observed serum drug concentration (tmax)

  From baseline to Day 140

• AUC from time 0 to the time of the last measurable drug concentration (AUC0-t)

  From baseline to Day 140

• Percentage extrapolation

  From baseline to Day 140

• Apparent serum terminal elimination rate constant (λz)

  From baseline to Day 140

Study Arms (2)

Reslizumab IV

EXPERIMENTAL

Reslizumab 220-mg administered Intravenously (IV)

Drug: Reslizumab IV

Reslizumab SC

EXPERIMENTAL

Reslizumab 220-mg administered Subcutaneously (SC)

Drug: Reslizumab SC

Interventions

Reslizumab IV DRUG

Reslizumab 220-mg intravenous (IV)

Reslizumab IV

Reslizumab SC DRUG

Reslizumab 220 mg administered subcutaneous (SC)

Reslizumab SC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• All Subjects
• Written informed consent is obtained.
• The subject can read, speak, and write in English or Japanese (as applicable to the respective enrollment group).
• The subject is in good health as determined by medical and psychiatric history, physical examination, brief neurologic examination, ECG, serum chemistry, hematology, urinalysis, and serology.
• The subject, if a woman, is surgically sterile, 2 years postmenopausal, or, if of childbearing potential, is using a medically accepted method of contraception, and agrees to continued use of this method for the duration of the study and for 30 days after completion of the study. Acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year).
• The subject must be willing and able to comply with study restrictions and to remain at the clinic for the required duration at each visit. Non-Japanese Subjects
• The subject has Caucasian parents and grandparents.
• The subject is a man or woman 18 through 45 years of age with a body mass index (BMI) of 20.0 to 30.0 kg/m2, inclusive (Appendix A). Note: At least half of the subjects enrolled into each treatment group must be within the more stringent age and weight criteria noted below for Japanese subjects.
• Also, every effort should be made to enroll an approximately equal number of men and women.
• Japanese Subjects
• The subject is a man or woman 20 through 45 years of age weighing 50 through 80 kg with a BMI of less than 28.0 kg/m2. Note: Every effort should be made to enroll an approximately equal number of men and women.
• The subject was born in Japan.
• The subject has Japanese parents and grandparents.
• The subject has lived less than 5 years outside Japan.
• The subject has a Japanese passport.

You may not qualify if:

• The subject has any clinically significant uncontrolled medical conditions (treated or untreated).
• The subject has a clinically significant deviation from normal in ECG, physical examination, or brief neurologic examination findings, as determined by the investigator or the medical monitor.
• The subject is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
• The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery; a history of appendectomy is allowed).
• The subject has received reslizumab in a previous study.
• The subject has received an immunosuppressant drug or anti-interleukin-5 (anti-IL-5) antibody within 6 months before the dose of study drug.
• The subject has received any investigational drug (non-biologic) within 30 days or 5 half-lives (whichever is longer) before the dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the dose of study drug.
• The subject has participated in any investigative biologics study within 6 months or 5 half-lives (whichever is longer) before the dose of study drug.
• The subject has a known or suspected hypersensitivity or idiosyncratic reaction to anti-IL-5 antibodies, any compound present in the study drug, or monoclonal antibodies.
• The subject has a history of any clinically important drug, vaccine and/or other allergies or there is indication of potential for allergic reactions. Pharmacokinetic Study-Healthy Subjects Clinical Study Protocol Study C38072/1107 8
• The subject has received immunization with a live vaccine within 3 months prior to the dose of study drug or has immunization with a live or live attenuated vaccine planned within 3 months after the last dose of study drug.
• The subject had or was suspected of having a parasitic infestation/infection within 6 months before the dose of study drug.
• The subject has used any vitamins within 2 weeks before the dose of study drug or has used any systemic or topical prescription, or nonprescription (over-the-counter \[OTC\]) medication (except acetaminophen or ibuprofen) within 2 weeks or 5 half-lives (whichever is longer) before the dose of study drug.
• The subject has used any herbal or nutritional supplements within 2 weeks before the dose of study drug.
• The subject has donated blood or has a history of significant blood loss within 56 days prior to the dose of study drug.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (1)

Teva Investigational Site 10567

Anaheim, California, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2013
• First Posted: November 21, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 31, 2014

Record last verified: 2014-03

Locations

US (1)