- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989544
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)
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)
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Berlin, Germany, 14050
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and/or female subjects aged 18 to 65 years (inclusive) at the Screening Visit, with suitable veins for repeated venipuncture.
- 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.
- 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.
- 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.
- Intact normal skin without potentially obscuring tattoos, scars, pigmentation or lesions on the skin area intended for injection (abdomen, thigh, upper arm).
Exclusion Criteria:
- History of any clinically significant disease or disorder.
- History of anaphylactic reaction to biologic therapy.
- Acute upper or lower respiratory infection requiring antibiotics or antiviral medications.
- History of tuberculosis.
- History of known immunodeficiency disorder, including a positive human immunodeficiency virus, or the subject is taking antiretroviral medications.
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half lives prior to the Screening Visit.
- Current smokers or those who have smoked or used nicotine products including e-cigarettes within the 3 months prior to the Screening Visit.
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.
- Subjects who have previously received tezepelumab.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Tezepelumab via Vial-and-syringe
Participants will be randomized to a single dose of tezepelumab via SC administration with Vial-and-syringe
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Tezepelumab subcutaneous injection
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Experimental: Tezepelumab via APFS
Participants will be randomized to a single dose of tezepelumab via SC administration with APFS
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Tezepelumab subcutaneous injection
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Experimental: Tezepelumab via AI
Participants will be randomized to a single dose of tezepelumab via SC administration with AI
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Tezepelumab subcutaneous injection
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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To compare the AUCinf following single SC administration of tezepelumab using Vial-and-syringe, APFS, and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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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
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To compare the Cmax following single SC administration of tezepelumab using vial-and-syringe, APFS, and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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To determine the AUClast following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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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
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To determine time to Cmax (tmax) following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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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
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To determine t½λz following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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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
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To determine CL/F following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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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
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To determine Vz/F estimated by non compartmental analysis following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.
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At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113
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Presence of ADAs to tezepelumab
Time Frame: At Day 1, 15, 29, 71 and 113
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To evaluate the immunogenicity of single dose tezepelumab administered SC using Vial-and-syringe, APFS and AI
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At Day 1, 15, 29, 71 and 113
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Number of subjects with adverse events (AEs)/ serious adverse events (SAEs)
Time Frame: From screening (Day -28) to follow up period (Day 113)
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To determine the number of subjects with AEs/SAEs following single dose SC administration of tezepelumab using vial and syringe, APFS and AI.
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From screening (Day -28) to follow up period (Day 113)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Rainard Fuhr, Parexel
Publications and helpful links
General Publications
- Corren J, Ambrose CS, Sałapa K, Roseti SL, Griffiths JM, Parnes JR, Colice G. Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy. J Allergy Clin Immunol Pract. 2021 Dec;9(12):4334-4342.e6. doi: 10.1016/j.jaip.2021.07.045. Epub 2021 Aug 3.
- Zheng Y, Abuqayyas L, Megally A, Fuhr R, Salapa K, Downie J, Colice G. Tezepelumab Pharmacokinetics, Safety, and Tolerability After Administration via Vial-and-syringe, Accessorized Prefilled Syringe, or Autoinjector: A Randomized Trial in Healthy Volunteers. Clin Ther. 2021 Jan;43(1):142-155.e5. doi: 10.1016/j.clinthera.2020.11.014. Epub 2020 Dec 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- D5180C00012
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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