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Study to Evaluate Pharmacokinetic Comparability Between AZD7442 Co-formulation (AZD8895 + AZD1061) vs AZD8895 and AZD1061 Individually in Adult Healthy Participants

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ClinicalTrials.gov Identifier: NCT05166421
Recruitment Status : Recruiting
First Posted : December 22, 2021
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The study will assess pharmacokinetic (PK) comparability between different formulations of AZD7442, which is a combination of two individual monoclonal antibodies (mAbs), AZD8895 and AZD1061.

Condition or disease Intervention/treatment Phase
Corona Virus Disease Biological: AZD7442 Biological: AZD8895 (clonal cell line material) Biological: AZD1061 (clonal cell line material) Biological: AZD8895 (cell pool material) Biological: AZD1061 (cell pool material) Phase 1

Detailed Description:

This is a randomized, open label, three-arm, single dose, parallel group, multi-center, PK comparability study.

Eligible healthy participants will be randomized in a 1:1:1 ratio between the 3 treatment groups. Each participant will receive AZD7442 as either a single intramuscular (IM) dose (co-formulation; AZD8895 + AZD1061), or as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) from either clonal cell line material or cell pool material.

Following an observation and PK and pharmacodynamic (PD) sample collection, post-dose, participants will be discharged from the Clinical Unit. During the Follow-up Period of approximately 1 year, participants will return as outpatient follow-up visits until Day 361.

The total duration of the study for a participant will be approximately 389 days comprising of a Screening Period that can last up to 28 days, Treatment Period of 1 day, and a Follow up Period of 360 days.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1, Randomized, Open Label, Three-arm, Single Dose, Parallel Group Study to Compare AZD7442 (AZD8895 + AZD1061) Pharmacokinetic Exposure Following Intramuscular Administration as a Co-formulation Versus Administration From Two Separate Vials of the Individual Monoclonal Antibodies in Adult Healthy Participants
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : July 28, 2023
Estimated Study Completion Date : July 28, 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: AZD7442 (co-formulation)
Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1.
 Biological: AZD7442
AZD7442 will be administered via IM route.
Active Comparator: AZD8895 and AZD1061 (clonal cell line material)
Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
 Biological: AZD8895 (clonal cell line material)
AZD8895 will be administered via IM route.

Biological: AZD1061 (clonal cell line material)
AZD1061 will be administered via IM route.
Active Comparator: AZD8895 and AZD1061 (cell pool material)
Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
 Biological: AZD8895 (cell pool material)
AZD8895 will be administered via IM route.

Biological: AZD1061 (cell pool material)
AZD1061 will be administered via IM route.


Outcome Measures
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Primary Outcome Measures :
  1. Area under serum concentration-time curve from time zero extrapolated to infinity (AUCinf) [ Time Frame: Day 1 until Day 361 (Post-dose) ]
    PK (AUCinf) comparability between: a) AZD7442 administered as a single IM dose (co-formulation) (AZD8895 + AZD1061) versus two separate IM doses (AZD8895 and AZD1061) (clonal cell line material and cell pool material of AZD8895 and AZD1061), and b) clonal cell line material versus the cell pool material of AZD7442 administered as two separate sequential IM doses (AZD8895 and AZD1061) of the individual mAbs will be evaluated in healthy adult participants.

  2. Area under the serum concentration-time curve from time zero to the last quantifiable concentration (AUClast) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (AUClast) comparability between: a) AZD7442 administered as a single IM dose (co-formulation) (AZD8895 + AZD1061) versus two separate IM doses (AZD8895 and AZD1061) (clonal cell line material and cell pool material of AZD8895 and AZD1061), and b) clonal cell line material versus the cell pool material of AZD7442 administered as two separate sequential IM doses (AZD8895 and AZD1061) of the individual mAbs will be evaluated in healthy adult participants.

  3. Maximum observed serum (peak) concentration (Cmax) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (Cmax) comparability between: a) AZD7442 administered as a single IM dose (co-formulation) (AZD8895 + AZD1061) versus two separate IM doses (AZD8895 and AZD1061) (clonal cell line material and cell pool material of AZD8895 and AZD1061), and b) clonal cell line material versus the cell pool material of AZD7442 administered as two separate sequential IM doses (AZD8895 and AZD1061) of the individual mAbs will be evaluated in healthy adult participants.

  4. Area under the serum concentration-time curve from time zero to 90 days post dose (AUC0-91d) (for interim analysis only) [ Time Frame: Day 1 (Pre-dose [Time Zero] and Post-dose) until Day 90 (Post-dose) ]
    PK (AUC0-91d) comparability between: a) AZD7442 administered as a single IM dose (co-formulation) (AZD8895 + AZD1061) versus two separate IM doses (AZD8895 and AZD1061) (clonal cell line material and cell pool material of AZD8895 and AZD1061), and b) clonal cell line material versus the cell pool material of AZD7442 administered as two separate sequential IM doses (AZD8895 and AZD1061) of the individual mAbs will be evaluated in healthy adult participants.


Secondary Outcome Measures :
  1. Time to reach maximum observed serum concentration (Tmax) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (Tmax) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  2. Area under the serum concentration-time curve from time zero to 30 days post dose (AUC0-31d) [ Time Frame: Day 1 (Pre-dose [Time Zero] and Post-dose) until Day 30 (Post-dose) ]
    PK (AUC0-31d) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  3. Area under the serum concentration-time curve from time zero to 60 days post dose (AUC0-61d) [ Time Frame: Day 1 (Pre-dose [Time Zero] and Post-dose) until Day 60 (Post-dose) ]
    PK (AUC0-61d) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  4. Time of last quantifiable serum concentration (tlast) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (tlast) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  5. Area under the serum concentration-time curve from time zero to 90 days post dose (AUC0-91d) [ Time Frame: Day 1 (Pre-dose [Time Zero] and Post-dose) until Day 90 (Post-dose) ]
    PK (AUC0-91d) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  6. Area under the serum concentration-time curve from time zero to 180 days post dose (AUC0-181d) [ Time Frame: Day 1 (Pre-dose [Time Zero] and Post-dose) until Day 180 (Post-dose) ]
    PK (AUC0-181d) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  7. Terminal elimination half-life, estimated as (ln2)/λz (t½λz) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (t½λz) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  8. Apparent total body clearance after extravascular administration (CL/F) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (CL/F) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  9. Volume of distribution (apparent) based on terminal phase after extravascular administration (Vz/F) [ Time Frame: Day 1 until Follow-up visit (Day 361) ]
    PK (Vz/F) following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  10. Number of participants with adverse events (AEs) [ Time Frame: From Screening (Day -28 to -1) until Follow-up visit (Day 361) ]
    Safety of AZD7442 following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.

  11. Number of participants with positive anti-AZD8895 and anti-AZD1061 antibodies [ Time Frame: Day 1 (Pre-dose) until Follow-up visit (Day 361) ]
    The ADA responses to AZD7442 in serum following administration of AZD7442 as a single IM dose (co-formulation) (AZD8895 + AZD1061) and two separate IM doses (AZD8895 and then AZD1061) (clonal cell line or cell pool material) of the individual mAbs will be assessed in healthy adult participants.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy participants according to medical history, physical examination, and baseline safety laboratory tests.
  • Documented negative results of a Severe Acute Respiratory Syndrome Corona Virus 2 reverse transcriptase polymerase chain reaction (SARS-CoV-2 RT-PCR) test collected ≤ 3 days prior to investigational medicinal drug (IMP) dose administration (Day 1) or a negative rapid SARS-CoV-2 antigen test on Day 1 (pre-dose).
  • Able to complete the Follow-up period up to Day 361 as required by the protocol.
  • Body weight ≥ 50 kg to ≤ 110 kg at screening and a Body mass index ≥ 18.0 to ≤ 30 kg/m^2 at the time of the Screening Visit.

Exclusion Criteria:

  • Known history of allergy or reaction to any component of AZD7442 (AZD8895 + AZD1061).
  • History of infection with SARS or Middle East Respiratory Syndrome.
  • Positive SARSCoV-2 result based on available data at screening or at Day 1.
  • Any clinical signs and symptoms consistent with Corona virus disease 2019 (COVID-19), eg, fever, dry cough, dyspnea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
  • History of clinically significant bleeding disorder.
  • Active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening.
  • Immunodeficiency due to illness, including HIV infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone.
  • Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study
  • Hemoglobin or platelet count below the lower limit of normal at screening.
  • Any prior receipt of another mAb indicated for the prevention or treatment of SARS CoV-2 or COVID-19.
  • Receipt of a mAb within 6 months or 5 antibody half-lives.
  • Receipt of a COVID-19 vaccination ≤ 14 days before IMP administration (Day 1) or plan to receive a COVID-19 vaccination ≤ 14 days after IMP dose (such participants can subsequently be included in the study once they have reached > 14 days after their last dose of vaccine).
Contacts and Locations
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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): NCT05166421


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

Locations
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United States, Alabama
Research Site Not yet recruiting
Anniston, Alabama, United States, 36207
Research Site Not yet recruiting
Cullman, Alabama, United States, 35055
United States, Arizona
Research Site Active, not recruiting
Scottsdale, Arizona, United States, 85260
United States, California
Research Site Recruiting
La Mesa, California, United States, 91942
Research Site Active, not recruiting
La Mesa, California, United States, 91942
Research Site Recruiting
Long Beach, California, United States, 90806
Research Site Recruiting
North Hollywood, California, United States, 91606
United States, Florida
Research Site Recruiting
Edgewater, Florida, United States, 32132
Research Site Recruiting
Lake Worth, Florida, United States, 33462
Research Site Recruiting
Orlando, Florida, United States, 320919
United States, Idaho
Research Site Recruiting
Meridian, Idaho, United States, 83642
United States, New Jersey
Research Site Recruiting
Berlin, New Jersey, United States, 08009
United States, South Carolina
Research Site Recruiting
Union, South Carolina, United States, 29379
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77058
Sponsors and Collaborators
AstraZeneca
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT05166421    
Other Study ID Numbers: D8850C00009
First Posted: December 22, 2021    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Time Frame:

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
Access Criteria:

When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:

https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AstraZeneca:
Monoclonal antibodies
Adult healthy participants
Additional relevant MeSH terms:
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Virus Diseases
Infections