| Primary | Maximum Observed Plasma Concentration (Cmax) of Depemokimab | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Micrograms per milliliter | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00014.68± 24.17
- OG00114.97± 23.29
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| Primary | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC[0-inf]) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Day*microgram/mL | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Area Under the Concentration-time Curve From Time Zero to Time of Last Observed Quantifiable Concentration (AUC[0-t]) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Day*microgram/mL | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. | Posted | | Median | Full Range | Day | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Apparent Clearance Following Extravascular Administration (CL/F) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/day | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Apparent Volume of Distribution Following Extravascular Administration (Vd/F) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Terminal Elimination Rate Constant (Lambda z) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Per day | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Terminal Elimination Half-Life (T1/2) Following Administration of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Day | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Time of Last Measurable Plasma Concentrations (Tlast) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. | Posted | | Mean | Standard Deviation | Day | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Percentage of AUC (0-Inf) Due to Extrapolation From the Time of the Last Observed Concentration (Tlast) to Infinity (%AUCex) of Depemokimab | Blood samples were collected at indicated time points for PK analysis of depemokimab. PK analysis was conducted using standard non-compartmental methods. The percentage of AUC (0-inf) obtained by extrapolation (%AUCex) was calculated as: (AUC[0-inf] - AUC[0-t]) /AUC(0-inf)*100. | Pharmacokinetic Population consisted of all participants in the Safety analysis set for whom at least one evaluable pharmacokinetic sample was obtained and analyzed. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Percentage of AUC extrapolation | | Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Number of Participants With Presence of Positive Anti-depemokimab Antibodies | Blood samples were collected and analyzed for the presence of anti- depemokimab antibodies using a validated immunoassay. The assay involved screening, confirmation and titration steps. If serum samples tested positive in the screening assay, they were considered 'potentially positive' and were further analyzed for the specificity using the confirmation assay. Samples that confirmed positive in the confirmation assay were reported as 'positive'. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | Safety Population included all participants who received at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | | Count of Participants | | Participants | | Baseline (Day 1), Weeks 4, 8, 12 and 26 | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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| Secondary | Number of Participants With Positive Neutralizing Antibodies to Depemokimab | Blood samples were collected for determination of positive neutralizing antibodies. A neutralizing antibody assay was performed. Neutralizing antibody test was only carried out for participants who have had a positive confirmatory binding antibody test result at visit. A participant was considered positive if they had at least one positive post-Baseline neutralizing antibody result. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. | Safety Population included all participants who received at least 1 dose of study intervention. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the 'Overall Number of Participants Analyzed' field. 'Number Analyzed' signifies participants evaluable for specified time points. | Posted | | Count of Participants | | Participants | | Baseline (Day 1), Weeks 4, 8, 12 and 26 | | | | ID | Title | Description |
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| OG000 | Depemokimab Via SSD | Participants received a single subcutaneous dose of 100 milligrams (mg) of depemokimab administered via a Safety Syringe Device (SSD) on Day 1. | | OG001 | Depemokimab Via Autoinjector | Participants received a single subcutaneous dose of 100 mg of depemokimab administered via an autoinjector on Day 1. |
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