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

NCT05166421 | Completed Phase 1 Results FDA Drug

• 1 other identifier: D8850C00009
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 14

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.

Conditions

Corona Virus Disease

Keywords

Monoclonal antibodies; Adult healthy participants

Outcome Measures

Primary Outcomes (3)

• Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)

  The pharmacokinetic (PK \[AUCinf\]) comparability between AZD7442 administered as a single IM dose (co-formulation) of (AZD8895 + AZD1061) versus two separate IM doses of AZD8895 followed by AZD1061: using clonal cell line material of AZD8895 and AZD1061 was evaluated. The AUCinf comparability between the clonal cell line material and the cell pool material of AZD7442 administered as two separate sequential IM doses of AZD8895 followed by AZD1061 was also evaluated. day\*micrograms per milliliter (day\*μg/mL)

  Predose on Study Day 1 (2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose) and on Study Days 5, 8, 15, 22, 31, 61, 91, 181, 271 and 361

• Area Under the Serum Concentration-time Curve From Day Zero to the Last Measurable Concentration (AUClast)

  The PK (AUClast) comparability between AZD7442 administered as a single IM dose (co-formulation) of (AZD8895 + AZD1061) versus two separate IM doses of AZD8895 followed by AZD1061: using clonal cell line material of AZD8895 and AZD1061 was evaluated. The AUClast comparability between the clonal cell line material and the cell pool material of AZD7442 administered as two separate sequential IM doses of AZD8895 followed by AZD1061 was also evaluated.

  Predose on Study Day 1 (2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose) and on Study Days 5, 8, 15, 22, 31, 61, 91, 181, 271 and 361

• Maximum Observed Serum (Peak) Concentration (Cmax)

  The PK (Cmax) comparability between AZD7442 administered as a single IM dose (co-formulation) of (AZD8895 + AZD1061) versus two separate IM doses of AZD8895 followed by AZD1061: using clonal cell line material of AZD8895 and AZD1061 was evaluated. The Cmax comparability between the clonal cell line material and the cell pool material of AZD7442 administered as two separate sequential IM doses of AZD8895 followed by AZD1061 was also evaluated.

  Predose on Study Day 1 (2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose) and on Study Days 5, 8, 15, 22, 31, 61, 91, 181, 271 and 361

Secondary Outcomes (11)

• Time to Maximum Observed Serum Concentration (Tmax)

  Predose on Study Day 1 (2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose) and on Study Days 5, 8, 15, 22, 31, 61, 91, 181, 271 and 361

• Area Under the Serum Concentration-time Curve From Day Zero to 30 Days Post-dose (AUC0-31d)

  Study Day 1 (Predose, 2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose), and on Study Days 5, 8, 15, 22, and 31

• Area Under the Serum Concentration-time Curve From Day Zero to 60 Days Post-dose (AUC0-61d)

  Study Day 1 (Predose, 2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose), and on Study Days 5, 8, 15, 22, 31 and 61

• Area Under the Serum Concentration-time Curve From Day Zero to 90 Days Post-dose (AUC0-91d)

  Study Day 1 (Predose, 2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose), and on Study Days 5, 8, 15, 22, 31, 61 and 91

• Area Under the Serum Concentration-time Curve From Day Zero to 180 Days Post-dose (AUC0-181d)

  Study Day 1 (Predose, 2 hours, 4 hours, 8 hours post dose), Study Day 2 (24 hours post dose), and on Study Days 5, 8, 15, 22, 31, 61, 91, and 181

Study Arms (3)

AZD7442 (co-formulation)

EXPERIMENTAL

Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1.

Biological: AZD7442

AZD8895 and AZD1061 (clonal cell line material)

ACTIVE COMPARATOR

Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.

Biological: AZD8895 (clonal cell line material); Biological: AZD1061 (clonal cell line material)

AZD8895 and AZD1061 (cell pool material)

ACTIVE COMPARATOR

Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.

Biological: AZD8895 (cell pool material); Biological: AZD1061 (cell pool material)

Interventions

AZD7442 BIOLOGICAL

AZD7442 will be administered via IM route.

AZD7442 (co-formulation)

AZD8895 (clonal cell line material) BIOLOGICAL

AZD8895 will be administered via IM route.

AZD8895 and AZD1061 (clonal cell line material)

AZD1061 (clonal cell line material) BIOLOGICAL

AZD1061 will be administered via IM route.

AZD8895 and AZD1061 (clonal cell line material)

AZD8895 (cell pool material) BIOLOGICAL

AZD8895 will be administered via IM route.

AZD8895 and AZD1061 (cell pool material)

AZD1061 (cell pool material) BIOLOGICAL

AZD1061 will be administered via IM route.

AZD8895 and AZD1061 (cell pool material)

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (14)

Research Site

Anniston, Alabama, 36207, United States

Location

Research Site

Cullman, Alabama, 35055, United States

Location

Research Site

Scottsdale, Arizona, 85260, United States

Location

Research Site

Chula Vista, California, 91911, United States

Location

Research Site

La Mesa, California, 91942, United States

Location

Research Site

Long Beach, California, 90806, United States

Location

Research Site

North Hollywood, California, 91606, United States

Location

Research Site

Edgewater, Florida, 32132, United States

Location

Research Site

Lake Worth, Florida, 33462, United States

Location

Research Site

Orlando, Florida, 320919, United States

Location

Research Site

Meridian, Idaho, 83642, United States

Location

Research Site

Berlin, New Jersey, 08009, United States

Location

Research Site

Union, South Carolina, 29379, United States

Location

Research Site

Houston, Texas, 77058, United States

Location

Related Links

• Redacted\_CSR\_Synopsis
• Redacted\_CSP
• Redacted\_SAP

MeSH Terms

Interventions

cilgavimab and tixagevimab drug combination; tixagevimab; cilgavimab

Results Point of Contact

• Title: Global Clinical Lead
• Organization: AstraZeneca Clinical Study Information Center

Information.center@astrazeneca.com

1-877-240-9479

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: November 24, 2021
• First Posted: December 22, 2021
• Study Start: November 30, 2021
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: November 25, 2024
• Results First Posted: November 25, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (14)