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

NCT03989544 | Completed Phase 1 FDA Drug

• 1 other identifier: D5180C00012
• Study Type: interventional
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Pharmacokinetics; Human monoclonal antibody; Tezepelumab; Accessorized Pre-filled Syringe; Autoinjector

Outcome Measures

Primary Outcomes (2)

• The area under the time concentration curves from zero to infinity (AUCinf)

  To compare the AUCinf following single SC administration of tezepelumab using Vial-and-syringe, APFS, and AI.

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

• The maximum observed concentration (Cmax)

  To compare the Cmax following single SC administration of tezepelumab using vial-and-syringe, APFS, and AI.

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

Secondary Outcomes (7)

• The areas under the time concentration curves from zero to last observation (AUClast)

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

• Time to Cmax (tmax)

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

• Terminal phase elimination half life (t½λz)

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

• Apparent systemic clearance (CL/F)

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

• Apparent terminal phase volume of distribution (Vz/F)

  At Days 1, 2, 4, 5, 6, 7, 8, 10, 12, 15, 22, 29, 43, 57, 71, 85, 99, and 113

Study Arms (3)

Tezepelumab via Vial-and-syringe

EXPERIMENTAL

Participants will be randomized to a single dose of tezepelumab via SC administration with Vial-and-syringe

Biological: Tezepelumab

Tezepelumab via APFS

EXPERIMENTAL

Participants will be randomized to a single dose of tezepelumab via SC administration with APFS

Biological: Tezepelumab

Tezepelumab via AI

EXPERIMENTAL

Participants will be randomized to a single dose of tezepelumab via SC administration with AI

Biological: Tezepelumab

Interventions

Tezepelumab BIOLOGICAL

Tezepelumab subcutaneous injection

Tezepelumab via AI; Tezepelumab via APFS; Tezepelumab via Vial-and-syringe

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Amgen: collaborator

Study Sites (1)

Research Site

Berlin, 14050, Germany

Location

Related Publications (2)

• Corren J, Ambrose CS, Salapa 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.

  PMID: 34358701 DERIVED

• 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.

  PMID: 33380362 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dr. Rainard Fuhr

  Parexel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 16, 2019
• First Posted: June 18, 2019
• Study Start: June 19, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Locations

DE (1)