Corona Virus DiseasePhase 1NCT05166421

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

A Phase 1 study testing AZD7442, AZD8895 (clonal cell line material) and AZD1061 (clonal cell line material) in people with Corona Virus Disease, run by AstraZeneca at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Corona Virus Disease
What is being tested?: AZD7442, AZD8895 (clonal cell line material) and AZD1061 (clonal cell line material)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 224 participants
Where: 14 sitesUnited States
Study dates: 30 Nov 2021to 19 Jul 2023
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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).

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Research Site
Anniston, Alabama, 36207
Research Site
Berlin, New Jersey, 08009
Research Site
Chula Vista, California, 91911
Research Site
Cullman, Alabama, 35055
Research Site
Edgewater, Florida, 32132
Research Site
Houston, Texas, 77058
Research Site
La Mesa, California, 91942
Research Site
Lake Worth, Florida, 33462
Research Site
Long Beach, California, 90806
Research Site
Meridian, Idaho, 83642
Research Site
North Hollywood, California, 91606
Research Site
Orlando, Florida, 320919
Research Site
Scottsdale, Arizona, 85260
Research Site
Union, South Carolina, 29379

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Corona Virus Disease
Being tested: AZD7442, AZD8895 (clonal cell line material), AZD1061 (clonal cell line material), AZD8895 (cell pool material), AZD1061 (cell pool material)
Keywords: Monoclonal antibodies, Adult healthy participants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD7442Biological
AZD7442 will be administered via IM route.
AZD8895 (clonal cell line material)Biological
AZD8895 will be administered via IM route.
AZD1061 (clonal cell line material)Biological
AZD1061 will be administered via IM route.
AZD8895 (cell pool material)Biological
AZD8895 will be administered via IM route.
AZD1061 (cell pool material)Biological
AZD1061 will be administered via IM route.

Study groups in NCT05166421
Study group	Role	What they receive
AZD7442 (co-formulation)	Experimental	Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1. Receives: 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. Receives: 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. Receives: Biological: AZD8895 (cell pool material); Biological: AZD1061 (cell pool material)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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.
Measured: 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.
Measured: 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)
The 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 were assessed in healthy adult participants.
Measured: 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)
The 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 were assessed in healthy adult participants.
Measured: 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)
The 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 were assessed in healthy adult participants.
Measured: 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)
The 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 were assessed in healthy adult participants.
Measured: 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)
The 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 were assessed in healthy adult participants.
Measured: 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
Time of Last Quantifiable Concentration (Tlast)
The 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 were assessed in healthy adult participants.
Measured: 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 382
Terminal Half-life (t½λz)
The 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 were assessed in healthy adult participants.
Measured: 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
Apparent Clearance After Extravascular Administration (CL/F)
The 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 were assessed in healthy adult participants.
Measured: 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
Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F)
The 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 were assessed in healthy adult participants.
Measured: 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
Number of Participants With Adverse Events (AEs)
The safety of AZD7442 when administered 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 in healthy adult participants was assessed.
Measured: From Day 1 until Follow-up visit (Day 361)
Number of Participants With Positive Anti-AZD8895 and Anti-AZD1061 Antibodies
The antidrug antibody (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 was assessed in healthy adult participants.
Measured: Day 1 (Pre-dose) until Follow-up visit (Day 361)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202119 Jul 2023

First posted22 Dec 2021
Study start30 Nov 2021
Primary completion19 Jul 2023
Study completion19 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Corona Virus DiseaseStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05166421
Sponsor's protocol ID: D8850C00009
Status last verified: Oct 2024
First submitted: 24 Nov 2021
Last updated: 25 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Zhang H, Tang W, Sadow S, Baronio R, Tullio AN, Hirao L, Dzutseva V, Chen CC, Kiazand A, Chang LJ, Cohen TS, Gibbs M. Pharmacokinetic Comparability Assessment of Tixagevimab and Cilgavimab Developed for COVID-19 Prevention and Treatment Using Standard Exposure Metrics and Partial Area Under the Curve. Clin Pharmacokinet. 2026 May;65(5):747-761. doi: 10.1007/s40262-026-01631-7. Epub 2026 Mar 31.
PubMed 41917376

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05166421
Acronym / sponsor ID: D8850C00009
Conditions: Corona Virus Disease
Keywords: Monoclonal antibodies, Adult healthy participants
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 30 Nov 2021 (actual)
Primary completion: 19 Jul 2023 (actual)
Study completion: 19 Jul 2023 (actual)
First posted: 22 Dec 2021 (actual)
Results: Posted 25 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
AZD7442 (co-formulation)	Experimental	Biological: AZD7442Participants will receive single dose of AZD7442 (co-formulation of AZD8895 + AZD1061) on Day 1.
AZD8895 and AZD1061 (clonal cell line material)	Active comparator	Biological: AZD8895 (clonal cell line material), Biological: AZD1061 (clonal cell line material)Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.
AZD8895 and AZD1061 (cell pool material)	Active comparator	Biological: AZD8895 (cell pool material), Biological: AZD1061 (cell pool material)Participants will receive two separate doses of the individual mAbs (AZD8895 and then AZD1061) on Day 1.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (11 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZD7442AZD7442 will be administered via IM route.	Biological	AZD7442 (co-formulation)
AZD8895 (clonal cell line material)AZD8895 will be administered via IM route.	Biological	AZD8895 and AZD1061 (clonal cell line material)
AZD1061 (clonal cell line material)AZD1061 will be administered via IM route.	Biological	AZD8895 and AZD1061 (clonal cell line material)
AZD8895 (cell pool material)AZD8895 will be administered via IM route.	Biological	AZD8895 and AZD1061 (cell pool material)
AZD1061 (cell pool material)AZD1061 will be administered via IM route.	Biological	AZD8895 and AZD1061 (cell pool material)

Primary outcome

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf)
Time frame: 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
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)
Area Under the Serum Concentration-time Curve From Day Zero to the Last Measurable Concentration (AUClast)
Time frame: 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
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.
Maximum Observed Serum (Peak) Concentration (Cmax)
Time frame: 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
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.

11 secondary outcomes

Time to Maximum Observed Serum Concentration (Tmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time of Last Quantifiable Concentration (Tlast)
Time frame: 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 382
Terminal Half-life (t½λz)
Time frame: 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
Apparent Clearance After Extravascular Administration (CL/F)
Time frame: 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
Volume of Distribution Based on Terminal Phase After Extravascular Administration (Vz/F)
Time frame: 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
Number of Participants With Adverse Events (AEs)
Time frame: From Day 1 until Follow-up visit (Day 361)
Number of Participants With Positive Anti-AZD8895 and Anti-AZD1061 Antibodies
Time frame: Day 1 (Pre-dose) until Follow-up visit (Day 361)

Results and safety

Results posted to the registry on 25 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material)	76	64
Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material)	72	67
Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material)	76	62

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

Time frame: 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. Geometric mean (Geometric Coefficient of Variation). Unit: day*μg/mL

Measure	Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) n = 63	Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) n = 65	Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) n = 62
AZD7442	4642 (43.12)	4980 (38.96)	4666 (41.06)
AZD8895	2357 (42.72)	2634 (37.13)	2405 (41.42)
AZD1061	2326 (42.69)	2333 (43.42)	2255 (41.70)

Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) vs Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material): Geometric mean ratio: 0.9380 (90% CI 0.8458 to 1.0403)
Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) vs Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material): Geometric mean ratio: 0.9968 (90% CI 0.8980 to 1.1066)
Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) vs Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material): Geometric mean ratio: 1.0627 (90% CI 0.9579 to 1.1790)

Population analysed: The PK analysis set consisted of all participants in the safety analysis set who received IMP and had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. Here, 'number of participants analyzed' specifies all participants who were evaluated for this outcome measure and 'number analyzed in each row' signifies the participants with available data that were analyzed for each drug for this outcome measure.

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

Measure	Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) n = 65	Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) n = 65	Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) n = 62
AZD7442	4362 (43.55)	4685 (38.60)	4406 (40.41)
AZD8895	2148 (47.37)	2464 (36.34)	2254 (40.54)
AZD1061	2191 (43.70)	2204 (43.62)	2145 (41.27)

Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) vs Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material): Geometric mean ratio: 0.9418 (90% CI 0.8512 to 1.0421)
Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) vs Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material): Geometric mean ratio: 0.9973 (90% CI 0.9004 to 1.1046)
Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) vs Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material): Geometric mean ratio: 1.0589 (90% CI 0.9559 to 1.1730)

Primary outcome: Maximum Observed Serum (Peak) Concentration (Cmax)

Measure	Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) n = 71	Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) n = 69	Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) n = 71
AZD7442	37.60 (40.64)	36.48 (40.28)	37.76 (33.64)
AZD8895	18.69 (41.33)	19.25 (37.01)	19.37 (33.26)
AZD1061	18.95 (42.15)	17.29 (47.17)	18.53 (36.49)

Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) vs Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material): Geometric mean ratio: 1.0308 (90% CI 0.9451 to 1.1243)
Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) vs Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material): Geometric mean ratio: 0.9930 (90% CI 0.9112 to 1.0822)
Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) vs Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material): Geometric mean ratio: 0.9634 (90% CI 0.8833 to 1.0507)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day 1 until Follow-up visit (Day 361). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material)	2 of 76 (2.6%)	2 of 76 (2.6%)	0 of 76
Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material)	0 of 72 (0%)	8 of 72 (11.1%)	0 of 72
Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material)	1 of 76 (1.3%)	10 of 76 (13.2%)	0 of 76

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41917376Zhang H, Tang W, Sadow S, Baronio R, Tullio AN, Hirao L, Dzutseva V, Chen CC, Kiazand A, Chang LJ, Cohen TS, Gibbs M. Pharmacokinetic Comparability Assessment of Tixagevimab and Cilgavimab Developed for COVID-19 Prevention and Treatment Using Standard Exposure Metrics and Partial Area Under the Curve. Clin Pharmacokinet. 2026 May;65(5):747-761. doi: 10.1007/s40262-026-01631-7. Epub 2026 Mar 31.
Redacted\_CSR\_SynopsisLink provided by the sponsor.
Redacted\_CSPLink provided by the sponsor.
Redacted\_SAPLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD7442, AZD8895 (clonal cell line material) and AZD1061 (clonal cell line material) in people with Corona Virus Disease, run by AstraZeneca at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05166421, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.