| Primary | 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) | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | | OG002 | Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (cell pool material) on Day 1. |
| | | Title | Denominators | Categories |
|---|
| AZD7442 | - ParticipantsOG00063
- ParticipantsOG00165
- ParticipantsOG00262
| |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Statistical Comparison of AUCinf of AZD7442 | | | | | Geometric mean ratio | 0.9380 | | | 2-Sided | 90 | 0.8458 | 1.0403 | | | | | Other | | | | Statistical Comparison of AUCinf of AZD7442 | |
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| Primary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. |
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| Primary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter (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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. |
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| Secondary | 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. | 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. | Posted | | Median | Full Range | Day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | | OG002 | Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) |
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| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*μg/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | |
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| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*μg/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | |
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| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*μg/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | |
|
| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | day*μg/mL | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | |
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| Secondary | 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. | 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. | Posted | | Median | Full Range | Day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | | OG002 |
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| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Day | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. |
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| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter per day (L/day) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. |
|
| Secondary | 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. | 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. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liter (L) | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. |
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| Secondary | 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. | The safety analysis set included all participants who were randomized and received any amount of IMP. | Posted | | Count of Participants | | Participants | | From Day 1 until Follow-up visit (Day 361) | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | | OG002 | Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (cell pool material) on Day 1. |
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| Secondary | 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. | The AZD8895 and AZD1061 ADA Evaluable Analysis Set included participants with at least 1 baseline and 1 post-baseline AZD8895 and AZD1061 ADA measurement. Here, 'number analyzed in each row' signifies the participants with available data that were analyzed for each drug for that outcome measure. | Posted | | Count of Participants | | Participants | | Day 1 (Pre-dose) until Follow-up visit (Day 361) | | | | ID | Title | Description |
|---|
| OG000 | Treatment A: AZD8895 and AZD1061 (Coformulation, Clonal Cell Line Material) | Participants received AZD7442 as a single intramuscular (IM) dose (co-formulation of AZD8895 + AZD1061) (clonal cell line material) on Day 1. | | OG001 | Treatment B: AZD8895 and AZD1061 (Separate Vials, Clonal Cell Line Material) | Participants received AZD7442 as two separate IM doses of the individual mAbs (AZD8895 and then AZD1061) (clonal cell line material) on Day 1. | | OG002 | Treatment C: AZD8895 and AZD1061 (Separate Vials, Cell Pool Material) |
|