COVID-19
Conditions
Keywords
Coronavirus, Severe acute respiratory syndrome coronavirus 2, Pharmacokinetics, Safety and tolerability
Brief summary
In this first-in-humans dose escalation study, AZD7442 (AZD8895 + AZD1061) will be evaluated for safety, tolerability, pharmacokinetics, and generation of anti-drug antibodies (ADAs). The study is intended to enable future studies of AZD7442's efficacy in preventing and treating COVID-19.
Detailed description
This is a Phase I, first time in human, randomised, double-blind, placebo-controlled, and dose escalation study. The study will comprise of: 1. A Screening Period of up to 27 days (Day -28 through Day -2); 2. A Treatment Period during which participants will be resident at the Clinical Unit from Day -1, 1 day before Investigational Medicinal Product (IMP) administration (on Day 1) until at least 24 hours after IMP administration, will be discharged on Day 2 after all safety evaluations have been completed, and 3. A Follow up Period lasting 360 days (through to Day 361) after the IMP dose. The study will be conducted at a single study centre in United Kingdom.
Interventions
COMBINATION_PRODUCTAZD7442
Participants randomized to AZD7442 will be administered dose 1, each in Cohort 1a (IM) and Cohort 1b (IV). Participants in Cohort 2 and 3 will receive AZD7442 (IV) doses 2 and 3, respectively. Participants in Cohort 4 will receive AZD7442 (IV) dose 4.
OTHERPlacebo
Participants randomised to placebo will receive the same volume of solution as participants on active treatment.
Sponsors
Parexel
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
The study will be blinded for all placebo controlled dose groups, ie, the Principal Investigator (PI), all clinical staff involved in the clinical study, the participants, and the study monitor will remain blinded, unless safety concerns or a regulatory requirement necessitate unblinding.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent and any locally required authorisation obtained from the participant prior to performing any protocol-related procedures, including screening evaluations. * Negative SARS-CoV-2 qRT-PCR and/or serology tests prior to randomisation. * Weight ≥ 50 kg and ≤ 110 kg at screening, including a BMI of ≥ 18.0 to ≤ 30.0 kg/m\^2. * Healthy by medical history, physical examination, and baseline safety laboratory studies, according to the judgement of the PI. * Electrocardiogram without clinically significant abnormalities at screening. * Able to complete the Follow-up Period through Day 361. * Females of childbearing potential who are sexually active with a non-sterilised male partner must have used a highly effective method of contraception for at least 28 days prior to dosing with IMP and must agree to continue using such precautions until the Final Follow-up Visit. Periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception.
Exclusion criteria
* Known hypersensitivity to any component of the IMP. * History of allergic disease or reactions likely to be exacerbated by any component of the IMP. * Previous hypersensitivity, infusion-related reaction or severe adverse reaction following administration of a mAbs. * Acute (time-limited) illness, including fever above 37.5°C (99.5 °F), on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the 27-day Screening Period or may be rescreened once. * Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use of acetaminophen, aspirin, antihistamine, or combination over the counter (OTC) product that contains acetaminophen with an antihistamine, or OTC nonsteroidal anti-inflammatory agent at a dose equal to or lower than that recommended on the package). Vitamins and other nutritional supplements that are not newly introduced, ie, have been taken for at least 30 days prior to enrolment, are not exclusionary. * Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months prior to screening. * Receipt of immunoglobulin or blood products within 6 months prior to screening. * SARS CoV-2 or COVID-19: * Participants with any confirmed current or previous COVID-19 infection before randomisation. * Participant has clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission. * Any prior receipt of investigational or licensed vaccine indicated for the prevention of SARS CoV-2 or COVID-19 or expected receipt during the period of study follow up. * Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study. * Previous receipt of a mAb within 6 months, or five antibody half lives (whichever is longer), prior to study start. * Immunodeficiency due to illness, including Human immunodeficiency virus (HIV) infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening. HIV testing must be negative at screening. * Either history of active infection with hepatitis B or C or positive test for hepatitis C or for hepatitis B surface antigen at screening. * History of infection with SARS or MERS. * Aspartate aminotransferase, ALT, or serum creatinine above the ULN; bilirubin and ALP \>1.5 × ULN. * Haemoglobin or platelet count below the LLN at screening. White blood cell or neutrophil count outside normal references ranges. * History of malignancy. * Any laboratory value in the screening panel that, in the opinion of the PI, is clinically significant or might confound analysis of study results. * Pregnant or nursing female. * History of alcohol or drug abuse within the past 2 years that, according to the PI, might affect assessments of safety or ability of participant to comply with all study requirements OR positive urine drug or alcohol screening. * Any condition that, in the opinion of the PI, might compromise participant safety or interfere with evaluation of the IMP or interpretation of participant safety or study results. * Employees of the sponsor, clinical study site, or any other individuals involved with the conduct of the study, or immediate family members of such individuals. * Absence of suitable veins for blood sampling (IM and IV cohorts) and administration of IMP (IV cohorts).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs | From screening day (Day -28) until Follow-up/end of treatment visit (Day 361) | The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose tmax of AZD7442 and of the individual mAbs in serum was evaluated |
| Terminal Elimination Half-life (t½λz) of AZD7442 | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose t½λz of AZD7442 and of the individual mAbs in serum was evaluated. |
| Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose AUClast of AZD7442 and of the individual mAbs in serum was evaluated. |
| Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose AUCinf of AZD7442 and of the individual mAbs in serum was evaluated. The bioavailability (F) of AZD7442 Dose 1 administered by IM was calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895 and mAb AZD1061 is also presented. |
| Maximum Serum Concentration (Cmax) of AZD7442 | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose Cmax of AZD7442 and of the individual monoclonal antibodies (mAbs) in serum were evaluated. |
| Apparent Total Clearance (CL/F) of AZD7442 IM Injection | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose CL/F of AZD7442 and of the individual mAbs in serum was evaluated. |
| Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose Vz/F of AZD7442 and of the individual mAbs in serum was evaluated. |
| Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose Vss of AZD7442 and of the individual mAbs in serum was evaluated. |
| Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | Day 361 (Post dose) | The ADA response to AZD7442 in serum was evaluated. |
| Systemic Clearance (CL) of AZD7442 IV Infusion | Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h) | The single dose CL of AZD7442 and of the individual mAbs in serum was evaluated. |
Countries
United Kingdom
Participant flow
Recruitment details
A total of 60 healthy participants were enrolled at a single study center in the United Kingdom (UK) from 18 August 2020 to 19 0ctober 2021.
Pre-assignment details
Participants who met the inclusion and none of the exclusion criteria were enrolled to the study. A washout period was not included in this study.
Participants by arm
| Arm | Count |
|---|---|
| Pooled Placebo Participants received single intravenous infusion (IV) or intramuscular injection (IM) of placebo. | 10 |
| AZD7442 300 mg, IM Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intramuscular injection (IM) administered in 2 sequential injections, starting with 150 mg AZD8895 and followed by 150 mg AZD1061. | 10 |
| AZD7442 300 mg, IV Participants received 300 mg of AZD7442 (AZD8895 + AZD1061) via intravenous infusion (IV) administered in 2 sequential infusions, starting with 150 mg AZD8895 and followed by 150 mg AZD1061. | 10 |
| AZD7442 1000 mg, IV Participants received 1000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 500 mg AZD8895 and followed by 500 mg AZD1061. | 10 |
| AZD7442 3000 mg, IV Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion administered in 2 sequential infusions, starting with 1500 mg AZD8895 and followed by 1500 mg AZD1061. | 10 |
| AZD7442 3000 mg, IV Co-administered Participants received 3000 mg of AZD7442 (AZD8895 + AZD1061) via IV infusion, the investigational medicinal product (IMP) was co-administered as a single IV infusion containing both (1500 mg of AZD8895 and 1500 mg of AZD1061). | 10 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Pooled Placebo | AZD7442 300 mg, IM | AZD7442 300 mg, IV | AZD7442 1000 mg, IV | AZD7442 3000 mg, IV | AZD7442 3000 mg, IV Co-administered | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 38.1 Years STANDARD_DEVIATION 11.45 | 41.9 Years STANDARD_DEVIATION 6.51 | 40.7 Years STANDARD_DEVIATION 7.83 | 38.9 Years STANDARD_DEVIATION 8.86 | 35.8 Years STANDARD_DEVIATION 9.44 | 39.6 Years STANDARD_DEVIATION 9.3 | 39.17 Years STANDARD_DEVIATION 8.86 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 10 Participants | 10 Participants | 10 Participants | 10 Participants | 59 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) White | 6 Participants | 6 Participants | 7 Participants | 8 Participants | 6 Participants | 7 Participants | 40 Participants |
| Sex: Female, Male Female | 5 Participants | 2 Participants | 6 Participants | 3 Participants | 3 Participants | 4 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 4 Participants | 7 Participants | 7 Participants | 6 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 8 / 10 | 2 / 10 | 5 / 10 | 6 / 10 | 7 / 10 | 6 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious AEs
The safety and tolerability of AZD7442 administered IV or IM to healthy adult participants 18 to 55 years of age was evaluated.
Time frame: From screening day (Day -28) until Follow-up/end of treatment visit (Day 361)
Population: Safety analysis set included all participants who were randomized and received any amount of AZD7442.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE | 8 Participants |
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to dose interruption | 0 Participants |
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE with outcome of death | 0 Participants |
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to withdrawal from the study | 0 Participants |
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Any SAE (including events with outcome of death) | 0 Participants |
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Ant AE leading to dose reduction | 0 Participants |
| Pooled Placebo | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to discontinuation of Investigational Medicinal Product (IMP) | 0 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE with outcome of death | 0 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to discontinuation of Investigational Medicinal Product (IMP) | 0 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Any SAE (including events with outcome of death) | 0 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to dose interruption | 0 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE | 2 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to withdrawal from the study | 0 Participants |
| AZD7442 300 mg, IM | Number of Participants With Adverse Events (AEs) and Serious AEs | Ant AE leading to dose reduction | 0 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any SAE (including events with outcome of death) | 0 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE with outcome of death | 0 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE | 5 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to dose interruption | 0 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Ant AE leading to dose reduction | 0 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to discontinuation of Investigational Medicinal Product (IMP) | 0 Participants |
| AZD7442 300 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to withdrawal from the study | 0 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to discontinuation of Investigational Medicinal Product (IMP) | 0 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE | 6 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE with outcome of death | 0 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any SAE (including events with outcome of death) | 0 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to dose interruption | 0 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Ant AE leading to dose reduction | 0 Participants |
| AZD7442 1000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to withdrawal from the study | 0 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any SAE (including events with outcome of death) | 0 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE with outcome of death | 0 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to withdrawal from the study | 0 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE | 7 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Ant AE leading to dose reduction | 0 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to discontinuation of Investigational Medicinal Product (IMP) | 0 Participants |
| AZD7442 3000 mg, IV | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to dose interruption | 1 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to withdrawal from the study | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to dose interruption | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Any SAE (including events with outcome of death) | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE with outcome of death | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Ant AE leading to dose reduction | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE | 6 Participants |
| AZD7442 3000 mg, IV Co-administered | Number of Participants With Adverse Events (AEs) and Serious AEs | Any AE leading to discontinuation of Investigational Medicinal Product (IMP) | 0 Participants |
Secondary
Apparent Total Clearance (CL/F) of AZD7442 IM Injection
The single dose CL/F of AZD7442 and of the individual mAbs in serum was evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the SAP and CSP to report CL/F for only arm receiving IM injection.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Apparent Total Clearance (CL/F) of AZD7442 IM Injection | AZD8895 | 0.06174 L (Litre)/day | Standard Deviation 0.01857 |
| Pooled Placebo | Apparent Total Clearance (CL/F) of AZD7442 IM Injection | AZD1061 | 0.07383 L (Litre)/day | Standard Deviation 0.02733 |
Secondary
Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442
The single dose Vz/F of AZD7442 and of the individual mAbs in serum was evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD8895 | 7.771 L (Litre) | Standard Deviation 2.152 |
| Pooled Placebo | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD1061 | 8.471 L (Litre) | Standard Deviation 2.832 |
| AZD7442 300 mg, IM | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD8895 | 5.150 L (Litre) | Standard Deviation 0.5804 |
| AZD7442 300 mg, IM | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD1061 | 6.042 L (Litre) | Standard Deviation 0.5914 |
| AZD7442 300 mg, IV | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD8895 | 6.814 L (Litre) | Standard Deviation 1.065 |
| AZD7442 300 mg, IV | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD1061 | 6.241 L (Litre) | Standard Deviation 0.9723 |
| AZD7442 1000 mg, IV | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD1061 | 6.449 L (Litre) | Standard Deviation 0.692 |
| AZD7442 1000 mg, IV | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD8895 | 6.227 L (Litre) | Standard Deviation 0.5926 |
| AZD7442 3000 mg, IV | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD8895 | 6.514 L (Litre) | Standard Deviation 0.7232 |
| AZD7442 3000 mg, IV | Apparent Volume of Distribution at Terminal Phase (Vz/F) of AZD7442 | AZD1061 | 6.324 L (Litre) | Standard Deviation 0.7784 |
Secondary
Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442
The single dose AUClast of AZD7442 and of the individual mAbs in serum was evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD8895 | 2367 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 28.92 |
| Pooled Placebo | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD1061 | 2018 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 30.98 |
| AZD7442 300 mg, IM | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD8895 | 3467 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 13.2 |
| AZD7442 300 mg, IM | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD1061 | 3085 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 13.01 |
| AZD7442 300 mg, IV | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD8895 | 9237 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.75 |
| AZD7442 300 mg, IV | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD1061 | 9245 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.22 |
| AZD7442 1000 mg, IV | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD1061 | 28160 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 10.85 |
| AZD7442 1000 mg, IV | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD8895 | 29800 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 9.799 |
| AZD7442 3000 mg, IV | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD8895 | 29380 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 10.81 |
| AZD7442 3000 mg, IV | Area Under the Concentration Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of AZD7442 | AZD1061 | 28210 day*μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.21 |
Secondary
Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442
The single dose AUCinf of AZD7442 and of the individual mAbs in serum was evaluated. The bioavailability (F) of AZD7442 Dose 1 administered by IM was calculated as the ratio of geometric mean AUCinf after IM to IV, for mAb AZD8895 and mAb AZD1061 is also presented.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD8895 | 2526 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 29.75 |
| Pooled Placebo | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD1061 | 2130 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 31.25 |
| AZD7442 300 mg, IM | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD8895 | 3677 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 13.75 |
| AZD7442 300 mg, IM | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD1061 | 3276 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 14.17 |
| AZD7442 300 mg, IV | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD8895 | 9893 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 12.58 |
| AZD7442 300 mg, IV | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD1061 | 9712 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.69 |
| AZD7442 1000 mg, IV | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD1061 | 29860 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.71 |
| AZD7442 1000 mg, IV | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD8895 | 31850 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 10.85 |
| AZD7442 3000 mg, IV | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD8895 | 31850 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.89 |
| AZD7442 3000 mg, IV | Area Under the Serum Concentration Versus Time Curve Extrapolated to Infinity (AUCinf) of AZD7442 | AZD1061 | 30030 day*ug/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.82 |
Comparison: Bioavailability of AZD8895 at the end of study (Day 361)
Comparison: Bioavailability of AZD1061 at the end of study (Day 361)
Secondary
Maximum Serum Concentration (Cmax) of AZD7442
The single dose Cmax of AZD7442 and of the individual monoclonal antibodies (mAbs) in serum were evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The Pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Maximum Serum Concentration (Cmax) of AZD7442 | AZD8895 | 16.52 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 35.56 |
| Pooled Placebo | Maximum Serum Concentration (Cmax) of AZD7442 | AZD1061 | 15.27 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 38.53 |
| AZD7442 300 mg, IM | Maximum Serum Concentration (Cmax) of AZD7442 | AZD8895 | 53.71 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 10.24 |
| AZD7442 300 mg, IM | Maximum Serum Concentration (Cmax) of AZD7442 | AZD1061 | 51.69 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 12.31 |
| AZD7442 300 mg, IV | Maximum Serum Concentration (Cmax) of AZD7442 | AZD8895 | 162.2 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.31 |
| AZD7442 300 mg, IV | Maximum Serum Concentration (Cmax) of AZD7442 | AZD1061 | 154.3 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 14.66 |
| AZD7442 1000 mg, IV | Maximum Serum Concentration (Cmax) of AZD7442 | AZD1061 | 465.5 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.09 |
| AZD7442 1000 mg, IV | Maximum Serum Concentration (Cmax) of AZD7442 | AZD8895 | 505.8 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 10.54 |
| AZD7442 3000 mg, IV | Maximum Serum Concentration (Cmax) of AZD7442 | AZD8895 | 447.8 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 8.98 |
| AZD7442 3000 mg, IV | Maximum Serum Concentration (Cmax) of AZD7442 | AZD1061 | 419.3 μg/mL (microgram per milliliter) | Geometric Coefficient of Variation 11.62 |
Secondary
Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061
The ADA response to AZD7442 in serum was evaluated.
Time frame: Day 361 (Post dose)
Population: Safety analysis set included all participants who were randomized and received any amount of AZD7442.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Pooled Placebo | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD8895 | 0 Participants |
| Pooled Placebo | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD1061 | 0 Participants |
| AZD7442 300 mg, IM | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD8895 | 1 Participants |
| AZD7442 300 mg, IM | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD1061 | 4 Participants |
| AZD7442 300 mg, IV | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD8895 | 0 Participants |
| AZD7442 300 mg, IV | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD1061 | 3 Participants |
| AZD7442 1000 mg, IV | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD8895 | 0 Participants |
| AZD7442 1000 mg, IV | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD1061 | 0 Participants |
| AZD7442 3000 mg, IV | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD8895 | 0 Participants |
| AZD7442 3000 mg, IV | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD1061 | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD8895 | 0 Participants |
| AZD7442 3000 mg, IV Co-administered | Percentage of Participants Who Have Positive Antidrug Antibodies (ADA) of AZD8895 and AZD1061 | AZD1061 | 0 Participants |
Secondary
Systemic Clearance (CL) of AZD7442 IV Infusion
The single dose CL of AZD7442 and of the individual mAbs in serum was evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the statistical analysis plan (SAP) and clinical study protocol (CSP) to report CL for only arms receiving IV infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD8895 | 0.04113 L (Litre)/day | Standard Deviation 0.005411 |
| Pooled Placebo | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD1061 | 0.04618 L (Litre)/day | Standard Deviation 0.006162 |
| AZD7442 300 mg, IM | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD1061 | 0.05180 L (Litre)/day | Standard Deviation 0.00626 |
| AZD7442 300 mg, IM | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD8895 | 0.05090 L (Litre)/day | Standard Deviation 0.00651 |
| AZD7442 300 mg, IV | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD8895 | 0.04736 L (Litre)/day | Standard Deviation 0.005317 |
| AZD7442 300 mg, IV | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD1061 | 0.05055 L (Litre)/day | Standard Deviation 0.006086 |
| AZD7442 1000 mg, IV | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD8895 | 0.04740 L (Litre)/day | Standard Deviation 0.005661 |
| AZD7442 1000 mg, IV | Systemic Clearance (CL) of AZD7442 IV Infusion | AZD1061 | 0.05026 L (Litre)/day | Standard Deviation 0.006036 |
Secondary
Terminal Elimination Half-life (t½λz) of AZD7442
The single dose t½λz of AZD7442 and of the individual mAbs in serum was evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD8895 | 87.76 Day | Geometric Coefficient of Variation 14.56 |
| Pooled Placebo | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD1061 | 79.78 Day | Geometric Coefficient of Variation 9.649 |
| AZD7442 300 mg, IM | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD8895 | 86.97 Day | Geometric Coefficient of Variation 5.195 |
| AZD7442 300 mg, IM | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD1061 | 91.08 Day | Geometric Coefficient of Variation 9.152 |
| AZD7442 300 mg, IV | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD8895 | 92.38 Day | Geometric Coefficient of Variation 17.23 |
| AZD7442 300 mg, IV | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD1061 | 83.05 Day | Geometric Coefficient of Variation 16.22 |
| AZD7442 1000 mg, IV | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD1061 | 88.52 Day | Geometric Coefficient of Variation 9.086 |
| AZD7442 1000 mg, IV | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD8895 | 91.27 Day | Geometric Coefficient of Variation 7.827 |
| AZD7442 3000 mg, IV | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD8895 | 95.33 Day | Geometric Coefficient of Variation 11.06 |
| AZD7442 3000 mg, IV | Terminal Elimination Half-life (t½λz) of AZD7442 | AZD1061 | 87.17 Day | Geometric Coefficient of Variation 10.78 |
Secondary
Time to Reach Maximum Serum Concentration (Tmax) of AZD7442
The single dose tmax of AZD7442 and of the individual mAbs in serum was evaluated
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pooled Placebo | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD1061 | 13.98 Day |
| Pooled Placebo | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD8895 | 13.96 Day |
| AZD7442 300 mg, IM | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD1061 | 0.02 Day |
| AZD7442 300 mg, IM | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD8895 | 0.04 Day |
| AZD7442 300 mg, IV | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD1061 | 0.02 Day |
| AZD7442 300 mg, IV | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD8895 | 0.04 Day |
| AZD7442 1000 mg, IV | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD8895 | 0.10 Day |
| AZD7442 1000 mg, IV | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD1061 | 0.06 Day |
| AZD7442 3000 mg, IV | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD1061 | 0.05 Day |
| AZD7442 3000 mg, IV | Time to Reach Maximum Serum Concentration (Tmax) of AZD7442 | AZD8895 | 0.05 Day |
Secondary
Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion
The single dose Vss of AZD7442 and of the individual mAbs in serum was evaluated.
Time frame: Day 1 (pre-dose, 8 h), Day 2 (24 h), Day 4 (72 h), Day 6 (120 h), Day 8 (168), Day 15 (336 h), Day 31 (720 h), Day 61 (1440 h), Day 91 (2160 h), Day 151 (3600 h), Day 211 (5040), Day 271 (6480 h), and Day 361 (8640 h)
Population: The PK analysis set consisted of all participants in the safety analysis set who received AZD7442 and who had evaluable serum PK data, with no important protocol deviations thought to impact on the analysis of the PK data. It was pre-specified in the SAP and CSP to report Vss for only arms receiving IV infusion.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pooled Placebo | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD8895 | 5.074 L (Litre) | Standard Deviation 0.4766 |
| Pooled Placebo | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD1061 | 5.687 L (Litre) | Standard Deviation 0.4691 |
| AZD7442 300 mg, IM | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD1061 | 6.020 L (Litre) | Standard Deviation 0.8755 |
| AZD7442 300 mg, IM | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD8895 | 6.520 L (Litre) | Standard Deviation 0.9739 |
| AZD7442 300 mg, IV | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD8895 | 6.118 L (Litre) | Standard Deviation 0.5983 |
| AZD7442 300 mg, IV | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD1061 | 6.311 L (Litre) | Standard Deviation 0.6722 |
| AZD7442 1000 mg, IV | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD8895 | 6.373 L (Litre) | Standard Deviation 0.6854 |
| AZD7442 1000 mg, IV | Volume of Distribution at Steady State (Vss) of AZD7442 IV Infusion | AZD1061 | 6.286 L (Litre) | Standard Deviation 0.7465 |