Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy subjects
This is a Phase I placebo-controlled study to assess the pharmacokinetics, safety and tolerability of 2 doses of anifrolumab via the subcutaneous (SC) route of administration and 1 dose of anifrolumab via intravenous (IV) route in healthy subjects
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anifrolumab 300 mg SC injections | Experimental | 300 mg single dose anifrolumab delivered as 2 separate 1 mL SC injections administered serially |
|
| Anifrolumab 300 mg IV infusion | Experimental | 300 mg single dose anifrolumab delivered as an IV infusion over 30 minutes |
|
| Anifrolumab 600 mg SC infusion | Experimental | 600 mg single dose anifrolumab or placebo delivered as 4 mL SC by infusion pump |
|
| Placebo 300 mg SC injections | Placebo Comparator | 300 mg single dose placebo delivered as 2 separate 1 mL SC injections administered serially |
|
| Placebo 300 mg IV infusion | Placebo Comparator | 300 mg single dose placebo delivered as an IV infusion over 30 minutes |
|
| Placebo 600mg SC infusion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anifrolumab SC injection (300mg) | Drug | 300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab. | To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total. | On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days |
| Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab | To evaluate AUC(0-t) of anifrolumab after single administration of two doses subcutaneously and one dose intravenously Up to 13 blood samples were collected in total. | On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days |
| Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab | To evaluate AUC of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total. | On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days |
| Safety: Number of Participants With Adverse Events (AEs) | To assess the safety and tolerability of single doses of anifrolumab | From screening to final follow-up visit, up to 16 weeks |
| Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants | Local injection site pain was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no pain" to 100 = "worst imaginable pain"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). | Immunogenicity was assessed in all groups by the presence or absence of ADA, which was determined in serum samples using validated bioanalytical methods. The reported results are based on the confirmatory assay (positive/negative) of the ADA. The number of participants with positive, negative and missing results are reported for each time point using the safety analysis set. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of any clinically significant disease or disorder which may put the subject at risk .
History or presence of hepatic or renal disease.
Any clinically significant illness, medical/surgical procedure, or trauma within 8 weeks of participation .
Any clinically significant chronic or recent infection requiring hospitalization or treatment with anti-infectives.
History of cancer, apart from squamous or basal cell carcinoma of the skin.
Any clinically significant lab, vital sign or ECG abnormalities as judged by the investigator.
Known history of a primary immunodeficiency,HIV splenectomy or an underlying condition.
Any positive result on screening for hepatitis B, hepatitis C or HIV antibody.
History of drug abuse within 1 year of participation.
Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 4 weeks or 5 half-lives prior to participation.
Previous receipt of:
History of allergy/hypersensitivity to drugs with a similar chemical structure or class to anifrolumab or to any human gamma globulin therapy.
Any live or attenuated vaccine within 8 weeks prior to participation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronald Goldwater, Dr. | PAREXEL Early Phase Clinical Unit, Baltimore, United States of America | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Baltimore | Maryland | 21225 | United States |
Not provided
| Label | URL |
|---|---|
| d3461c00006-revised-study-protocol-1\_REDACTED | View source |
Not provided
All eligible participants underwent a screening period of a maximum of 28 days. During the treatment period all participants were asked to be the residents at the study site prior to the evening meal the night before dosing with anifrolumab or placebo (Day -1) until at least 48 hours after dosing; and were then discharged on the morning of Day 3.
This study was conducted at the PAREXEL Early Phase Clinical Unit Baltimore, 3001 S. Hanover St.
Baltimore, MD 21225 United States of America
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Anifrolumab 300 mg SC Injections | Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. |
| FG001 | Anifrolumab 300 mg IV Infusion |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Comparator |
600 mg single dose placebo delivered as 4 mL SC by infusion pump |
|
| Anifrolumab IV infusion (300mg) | Drug | 300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1 |
|
| Anifrolumab SC infusion (600mg) | Drug | 600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1 |
|
| Anifrolumab placebo SC injection (300mg) | Drug | 300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1 |
|
| Anifrolumab placebo IV infusion (300mg) | Drug | 600mg of placebo delivered as an IV infusion over 30 minutes on Day 1 |
|
| Anifrolumab placebo SC infusion (600mg) | Drug | 600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1 |
|
| Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants | Local injection site pruritus was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no itching" to 100 = "worst imaginable itching"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported. | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants | Erythema was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported. | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants | Induration was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported. | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| Pre-dose and at Days 5 and Day 29, up to 85 days |
Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1
| FG002 | Anifrolumab 600 mg SC Infusion | Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1 |
| FG003 | Pooled Placebo | Randomized participants received Anifrolumab matching placebo. |
|
| COMPLETED | Participants |
|
| NOT COMPLETED |
|
|
Thirty healthy male and female subjects were included in this study, 6 subjects per anifrolumab treatment (300 mg anifrolumab SC, 300 mg anifrolumab IV, 600 mg anifrolumab SC) and 12 subjects for placebo treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Anifrolumab 300 mg SC Injections | Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. |
| BG001 | Anifrolumab 300 mg IV Infusion | Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1 |
| BG002 | Anifrolumab 600 mg SC Infusion | Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1 |
| BG003 | Pooled Placebo | Randomized participants received Anifrolumab matching placebo. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex/Gender, Customized | Number | Count of participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetics: Observed Maximum Serum Concentration (Cmax) Following Single Dose of Anifrolumab. | To evaluate Cmax of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total. | The pharmacokinetic (PK) analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data | Posted | Mean | Standard Deviation | ug/mL | On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Pharmacokinetics: Area Under the Serum Concentration-time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) Following Single Dose of Anifrolumab | To evaluate AUC(0-t) of anifrolumab after single administration of two doses subcutaneously and one dose intravenously Up to 13 blood samples were collected in total. | The PK analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data | Posted | Mean | Standard Deviation | day*μg/mL | On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days |
| |||||||||||||||||||||||||||||||||
| Primary | Pharmacokinetics: Area Under Serum Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC) Following Single Dose of Anifrolumab | To evaluate AUC of anifrolumab after single administration of two doses subcutaneously and one dose intravenously. Up to 13 blood samples were collected in total. | The PK analysis set consisted of all participants in the safety analysis set for whom at least 1 of the primary PK parameters could be calculated, and who had no major protocol deviations that had an impact on the analysis of the PK data | Posted | Mean | Standard Deviation | day*μg/mL | On Day 1 pre-dose and at 5 minutes (IV cohort only), 24 and 48 hours post-dose and at each follow-up visit, up to 85 days |
| |||||||||||||||||||||||||||||||||
| Primary | Safety: Number of Participants With Adverse Events (AEs) | To assess the safety and tolerability of single doses of anifrolumab | The safety analysis set included all participants who received at least 1 dose of investigational medicinal product (IMP) (anifrolumab or placebo) and for whom any safety post-dose data were available. | Posted | Number | Participants | From screening to final follow-up visit, up to 16 weeks |
| ||||||||||||||||||||||||||||||||||
| Primary | Safety: Summary of Local Injection Site Pain (SC Cohorts) Assessed in Participants | Local injection site pain was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no pain" to 100 = "worst imaginable pain"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported. | The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available. | Posted | Mean | Standard Deviation | Millimeter | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| |||||||||||||||||||||||||||||||||
| Primary | Safety: Summary of Local Injection Site Pruritus (SC Cohorts) Assessed in Participants | Local injection site pruritus was assessed using a 100 mm participant rated Visual Analog Scale (VAS 0mm - 100mm ungraduated scale, where 0 = "no itching" to 100 = "worst imaginable itching"). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average VAS score (0mm-100mm) of the two injection sites were reported. | The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available. | Posted | Mean | Standard Deviation | Millimeter | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| |||||||||||||||||||||||||||||||||
| Primary | Safety: Summary of Erythema Injection Site Reaction (SC Cohorts) Assessed in Participants | Erythema was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported. | The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available. | Posted | Mean | Standard Deviation | Millimeter | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
| |||||||||||||||||||||||||||||||||
| Secondary | Evaluation of Immunogenicity of Anifrolumab IV Infusions and SC Injections by the Measurement of Anti-drug Antibody (ADA). | Immunogenicity was assessed in all groups by the presence or absence of ADA, which was determined in serum samples using validated bioanalytical methods. The reported results are based on the confirmatory assay (positive/negative) of the ADA. The number of participants with positive, negative and missing results are reported for each time point using the safety analysis set. | The safety analysis set included all subjects who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available. | Posted | Number | Participants | Pre-dose and at Days 5 and Day 29, up to 85 days |
| ||||||||||||||||||||||||||||||||||
| Primary | Safety: Summary of the Induration Injection Site Reaction (SC Cohorts) Assessed in Participants | Induration was measured as the largest diameter across the needle site on the skin in millimetres (mm). This assessment was taken for only those participants in subcutaneously dosed treatment groups; 600 mg SC and 300 mg SC, anifrolumab and placebo. For the 300 mg SC anifrolumab and 300 mg SC placebo groups which received two simultaneous injections, the average of the two injection site diameters (mm) were reported. | The safety analysis set included all participants who received at least 1 dose of IMP (anifrolumab or placebo) and for whom any safety post-dose data were available. | Posted | Mean | Standard Deviation | Millimeter | Immediately after dosing, at 10, 20 minutes and 1 hour after injection |
|
From screening to final follow-up visit, up to 16 weeks
An adverse event (AE) is any undesirable medical condition or the deterioration of a pre existing medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anifrolumab 300 mg SC Injections | Participants received a single dose of anifrolumab 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | Anifrolumab 300 mg IV Infusion | Participants received single dose of anifrolumab 300 mg delivered as an intravenous (IV) infusion over 30 minutes on Day 1 | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | Placebo 300 mg Anifrolumab SC | Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG003 | Placebo 300 mg IV Infusion | Participants received 300 mg single dose placebo delivered as an IV infusion over 30 minutes on Day 1. | 0 | 4 | 0 | 4 | 1 | 4 |
| EG004 | Placebo 600 mg Anifrolumab (SC) | Participants received 600 mg single dose placebo delivered as 4 mL SC by infusion pump on Day 1. | 0 | 4 | 0 | 4 | 2 | 4 |
| EG005 | Anifrolumab 600 mg SC Infusion | Participants received single dose of anifrolumab 600 mg delivered as 4 mL SC by infusion pump on Day 1 | 0 | 6 | 0 | 6 | 4 | 6 |
| EG006 | Pooled Placebo | Randomized participants received Anifrolumab matching placebo. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG007 | All Anifrolumab Subjects | Overall number of participants who received anifrolumab therapy | 0 | 18 | 0 | 18 | 9 | 18 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 18.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA Version 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA Version 18.1 | Systematic Assessment |
| |
| Tinea pedis | Infections and infestations | MedDRA Version 18.1 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Infusion site pruritus | General disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Vessel puncture site bruise | General disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Food allergy | Immune system disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Menstrual disorder | Reproductive system and breast disorders | MedDRA Version 18.1 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 18.1 | Systematic Assessment |
|
All of the study information and data collected during the study are confidential and the property of AstraZeneca. After completion of the study, the investigator may prepare a joint publication with AstraZeneca. The investigator must undertake not to submit any part of the individual data from this study for publication without prior consent of AstraZeneca at a mutually agreed time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anifrolumab Global Clinical Leader | AstraZeneca AB | +46317761000 | ClinicalTrialTransparency@astrazeneca.com |
| Male |
|
|
|
|
|
Randomized participants received Anifrolumab matching placebo.
| OG004 | Placebo 300 mg Anifrolumab SC | Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. |
| OG005 | Placebo 600 mg Anifrolumab SC | Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump. |
| OG006 | Placebo 300 mg Anifrolumab IV | Participants received Single dose of placebo 300 mg delivered as an IV infusion over 30 minutes. |
| OG007 | All Anifrolumab Participants | Overall number of participants who received anifrolumab therapy. |
|
|
Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. |
| OG003 | Placebo 600 mg Anifrolumab SC | Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump. |
|
|
Participants received a single dose of placebo 300 mg delivered as 2 separate 1 mL subcutaneous (SC) injections administered serially on Day 1. |
| OG003 | Placebo 600 mg Anifrolumab SC | Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump. |
|
|
| OG003 | Placebo 600 mg SC Injection | Participants received placebo 600mg |
|
|
| OG003 | Pooled Placebo | Randomized participants received Anifrolumab matching placebo. |
| OG004 | All Subjects | Overall participants. |
|
|
| OG003 | Placebo 600 mg Anifrolumab SC | Participants received single dose of placebo 600 mg delivered as 4 mL SC by infusion pump. |
|
|