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A Study to Evaluate the Pharmacokinetics of Tezepelumab After Being Delivered by an Accessorized Pre Filled Syringe or Autoinjector Compared With Vial and Syringe in Healthy Adult Subjects (PATH-BRIDGE)

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ClinicalTrials.gov Identifier: NCT03989544
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
This is a study to compare PK of tezepelumab exposure in healthy subjects by using vial and syringe, APFS, and AI.

Condition or disease Intervention/treatment Phase
Asthma Biological: Tezepelumab Phase 1

Detailed Description:
This study will be a single center, randomized, open label, parallel group study designed to compare tezepelumab PK exposure in healthy subjects following single subcutaneous (SC) administration of a fixed dose of tezepelumab by using vial and syringe, APFS, or AI. A total of 315 subjects will be randomized to receive a single, fixed dose of tezepelumab administered SC using vial-and-syringe, APFS, or AI at 1 of 3 injection sites: abdomen, thigh or upper arm. Separate randomization lists will be produced for each weight group (50 to < 70 kg, 70 to < 80 kg, 80 to 90 kg), and within each of the 3 weight groups, subjects will be randomized 1:1:1:1:1:1:1:1:1 to 1 of the 9 combinations of treatment (vial-and-syringe, APFS, or AI) with injection site (abdomen, thigh, upper arm). Within each weight group, at least 36 subjects will be randomized resulting in at least 12 subjects per treatment group (device) within each weight group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Randomized, Parallel Group Study to Evaluate the Pharmacokinetics of Tezepelumab Administered Subcutaneously Via Accessorized Pre Filled Syringe (APFS) or Autoinjector (AI) Compared With Vial and Syringe in Healthy Adult Subjects (PATH-BRIDGE)
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : March 6, 2020
Estimated Study Completion Date : March 6, 2020

Arm Intervention/treatment
Experimental: Tezepelumab via Vial-and-syringe
Participants will be randomized to a single dose of tezepelumab via SC administration with Vial-and-syringe
Biological: Tezepelumab
Tezepelumab subcutaneous injection

Experimental: Tezepelumab via APFS
Participants will be randomized to a single dose of tezepelumab via SC administration with APFS
Biological: Tezepelumab
Tezepelumab subcutaneous injection

Experimental: Tezepelumab via AI
Participants will be randomized to a single dose of tezepelumab via SC administration with AI
Biological: Tezepelumab
Tezepelumab subcutaneous injection




Primary Outcome Measures :
  1. The area under the time concentration curves from zero to infinity (AUCinf) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To compare the AUCinf following single SC administration of tezepelumab using Vial-and-syringe, APFS, and AI.

  2. The maximum observed concentration (Cmax) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To compare the Cmax following single SC administration of tezepelumab using vial-and-syringe, APFS, and AI.


Secondary Outcome Measures :
  1. The areas under the time concentration curves from zero to last observation (AUClast) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To determine the AUClast following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.

  2. Time to Cmax (tmax) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To determine time to Cmax (tmax) following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.

  3. Terminal phase elimination half life (t½λz) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To determine t½λz following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.

  4. Apparent systemic clearance (CL/F) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To determine CL/F following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.

  5. Apparent terminal phase volume of distribution (Vz/F) [ Time Frame: At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113 ]
    To determine Vz/F estimated by non compartmental analysis following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.

  6. Presence of ADAs to tezepelumab [ Time Frame: At Day 1, 15, 29, 71 and 113 ]
    To evaluate the immunogenicity of single dose tezepelumab administered SC using Vial-and-syringe, APFS and AI

  7. Number of subjects with adverse events (AEs)/ serious adverse events (SAEs) [ Time Frame: From screening (Day -28) to follow up period (Day 113) ]
    To determine the number of subjects with AEs/SAEs following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Provision of signed and dated, written informed consent prior to any study specific procedures.
  2. Healthy male and/or female subjects aged 18 to 65 years (inclusive) at the Screening Visit, with suitable veins for repeated venipuncture.
  3. Females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit (Day 1) and must not be lactating.
  4. Females of childbearing potential who are sexually active must use a highly effective method of contraception from the Screening Visit and must agree to continue using such precautions for 16 weeks after the dose of Investigational Medicinal Product (IMP). Cessation of contraception after this point should be discussed with a responsible physician. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
  5. Have a body mass index between 18.5 and 30 kg/m2 inclusive and weigh at least 50 kg and no more than 90 kg inclusive.
  6. Intact normal skin without potentially obscuring tattoos, scars, pigmentation or lesions on the skin area intended for injection (abdomen, thigh, upper arm).

Exclusion Criteria:

  1. History of any clinically significant disease or disorder.
  2. History of anaphylactic reaction to biologic therapy.
  3. Acute upper or lower respiratory infection requiring antibiotics or antiviral medications.
  4. History of tuberculosis.
  5. History of known immunodeficiency disorder, including a positive human immunodeficiency virus, or the subject is taking antiretroviral medications.
  6. Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to the Screening Visit.
  7. Current smokers or those who have smoked or used nicotine products including e-cigarettes within the 3 months prior to the Screening Visit.
  8. History of cancer:

    Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the Screening Visit.

    Subjects who have had other malignancies including breast cancer are eligible provided that curative therapy was completed at least 5 years prior to the Screening Visit.

  9. Subjects who have previously received tezepelumab.

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): NCT03989544


Contacts
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Contact: AstraZeneca Clinical Study Information Center 1-877-240-9479 information.center@astrazeneca.com

Locations
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Germany
Research Site Recruiting
Berlin, Germany, 14050
Sponsors and Collaborators
AstraZeneca
Amgen
Investigators
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Principal Investigator: Dr. Rainard Fuhr Parexel

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT03989544     History of Changes
Other Study ID Numbers: D5180C00012
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AstraZeneca:
Pharmacokinetics
Human monoclonal antibody
Tezepelumab
Accessorized Pre-filled Syringe
Autoinjector
Additional relevant MeSH terms:
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Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs