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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004931-35 | EudraCT Number |
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The main objectives of this study were to estimate the absolute bioavailability of ravulizumab/rHuPH20 subcutaneous (SC) and to assess the safety and tolerability of ravulizumab/rHuPH20 SC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants received a single dose of ravulizumab SC 400 (milligrams) mg . |
|
| Cohort 2 | Experimental | Participants received a single dose of ravulizumab SC 500 mg/rHuPH20 10000 units. |
|
| Cohort 3 | Experimental | Participants received a single dose of ravulizumab SC 1000 mg/rHuPH20 20000 units. |
|
| Cohort 4 | Experimental | Participants received a single dose of ravulizumab SC 2000 mg/rHuPH20 40000 units. |
|
| Cohort 5 | Experimental | Participants received a single dose of ravulizumab intravenously (IV) 400 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravulizumab | Drug | Solution for infusion or injection, as applicable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Bioavailability Of Ravulizumab Subcutaneous (SC)/rHuPH20 | Dose-normalized area under the serum concentration versus time curve from 0 extrapolated to infinity (AUC0-inf) and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab intravenous (IV) cohort to determine absolute bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Absolute bioavailability is reported as the geometric mean ratio, which was defined as the ratio of geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab SC cohort divided by that for the ravulizumab IV cohort. | Day 1 (after first dose) to Day 200 |
| Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | An AE was reported as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AEs (SAEs) were defined as any untoward medical occurrence that, at any dose resulted in death, life threatening, required hospitalization, resulted in persistent disability or incapacity, resulted in birth defect, or other situations. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | Day 1 (after first dose) up to Day 200 (including safety follow up) |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Bioavailability Of Ravulizumab SC/rHuPH20 Compared With Ravulizumab SC | Dose-normalized AUC0-inf and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab SC cohort to determine relative bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Relative bioavailability is reported as the geometric mean ratio, which was defined as the ratio of the geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab/rHuPH SC cohort divided by that for the ravulizumab SC cohort. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Current or recurrent disease (for example, cardiovascular, hematological, neurological, endocrine, immunological, rheumatological, renal, hepatic or gastrointestinal or other conditions) that or could affect clinical assessments or clinical laboratory evaluations.
Current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
Any other significant disease or disorder which, in the opinion of the Investigator, may put the participant at risk.
Documented history of allergy to penicillin or cephalosporin.
History of significant allergic reaction (for example, anaphylaxis or angioedema) to any product (for example, food, pharmaceutical).
Use of prescription medications (excluding oral contraceptives) within 14 days prior to dosing on Day 1, except with prior approval of the Sponsor.
Regular use of nonprescription, over-the-counter medications, including herbal remedies and supplements, within 14 days prior to dosing on Day 1. Multivitamins, paracetamol (acetaminophen) ≤2 grams (g) per day, and topical skin products without significant systemic absorption are allowed.
Positive urine drug toxicology screen at screening or on Day -1.
Alcohol consumption within 48 hours prior to study drug administration or positive alcohol breath test on Day -1.
Donation of plasma within 7 days prior to dosing on Day 1. Donation or loss (excluding volume drawn at screening) of more than 50 milliliters (mL) of blood within 30 days prior to dosing or more than 499 mL of blood within 56 days prior to dosing on Day 1.
Female participants who are breastfeeding.
Participants who are in intimate and prolonged contact with (defined as living under the same roof or providing personal care to) people younger than 2 years of age or older than 65 years of age, or who are either immunocompromised or have one of the following underlying medical conditions: anatomic or functional asplenia (including sickle cell disease); congenital complement, properdin, factor D, or primary antibody deficiencies; acquired complement deficiencies (for example, those receiving eculizumab); or human immunodeficiency virus (HIV).
Participants who are one of the following:
Immunization with a live-attenuated vaccine 28 days prior to dosing on Day 1 or planned vaccination during the course of the study (except for the vaccination planned by the study protocol). Immunization with inactivated or recombinant influenza vaccine is permitted.
Prior exposure to ravulizumab or eculizumab.
Major surgery or hospitalization within 90 days prior to dosing on Day 1.
History of allergy or hypersensitivity to excipients of ravulizumab (for example, polysorbate 80), rHuPH20, or other hyaluronidases.
Currently smokes >10 cigarettes daily (former smokers may be permitted to enroll at the Investigator's discretion) and is unwilling to refrain from smoking while a resident in the clinical research unit or comply with the smoking restrictions.
History of illicit drug abuse, history of significant alcohol abuse within 1 year prior to the screening visit, or clinical evidence of substance and/or alcohol abuse within the 2 years before screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | London | United Kingdom |
A total of 108 potential participants were screened (including 5 rescreened and 59 rejects [screen fail]). A total of 49 participants were ultimately treated in this study.
Eligible participants who met all inclusion and no exclusion criteria were assigned unique numbers for enrollment and randomization. Randomization was only used when cohorts were enrolled in parallel.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 | Participants received a single dose of ravulizumab 400 mg (milligrams) subcutaneously. |
| FG001 | Cohort 2 | Participants received a single dose of ravulizumab 500 mg/recombinant human hyaluronidase PH20 (rHuPH20) 10000 units subcutaneously. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 20, 2018 | Jun 23, 2022 |
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|
| rHuPH20 | Drug | Solution for infusion |
|
|
| Day 1 (after first dose) to Day 200 |
| Maximum Percent Change From Baseline (PCFB) In Serum Levels Of Total Complement Component 5 (C5) Concentrations | The highest (maximum difference) mean (standard deviation [SD]) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100. | Baseline, Up to Day 200 |
| Maximum PCFB In Serum Levels Of Free C5 Concentrations | The highest (maximum difference) mean (SD) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100. | Baseline, Day 200 |
| Maximum PCFB In Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity | The highest (maximum difference) mean (SD) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100. | Baseline, Up to Day 200 |
| FG002 | Cohort 3 | Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously. |
| FG003 | Cohort 4 | Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously. |
| FG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. |
| Received at Least 1 Dose of Study Drug |
|
| COMPLETED |
|
| NOT COMPLETED |
|
The Safety Population included all participants who receive at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 | Participants received a single dose of ravulizumab 400 mg subcutaneously. |
| BG001 | Cohort 2 | Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously. |
| BG002 | Cohort 3 | Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously. |
| BG003 | Cohort 4 | Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously. |
| BG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. |
| BG005 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
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| 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 | Absolute Bioavailability Of Ravulizumab Subcutaneous (SC)/rHuPH20 | Dose-normalized area under the serum concentration versus time curve from 0 extrapolated to infinity (AUC0-inf) and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab intravenous (IV) cohort to determine absolute bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Absolute bioavailability is reported as the geometric mean ratio, which was defined as the ratio of geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab SC cohort divided by that for the ravulizumab IV cohort. | The Pharmacokinetics (PK) Population included all participants who had sufficient serum concentration data to enable the calculation of PK parameters of at least area under the serum concentration versus time curve (AUC). For this outcome measure, the Number of Participants Analyzed includes the participants from both the IV group and the respective SC group. | Posted | Geometric Mean | 95% Confidence Interval | Percent bioavailability | Day 1 (after first dose) to Day 200 |
|
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) | An AE was reported as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AEs (SAEs) were defined as any untoward medical occurrence that, at any dose resulted in death, life threatening, required hospitalization, resulted in persistent disability or incapacity, resulted in birth defect, or other situations. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. | The Safety Population included all participants who receive at least 1 dose of study drug. | Posted | Number | Participants | Day 1 (after first dose) up to Day 200 (including safety follow up) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Relative Bioavailability Of Ravulizumab SC/rHuPH20 Compared With Ravulizumab SC | Dose-normalized AUC0-inf and body weight-adjusted AUC0-inf for the ravulizumab/rHuPH20 SC cohorts were compared with the 400 mg ravulizumab SC cohort to determine relative bioavailability. Geometric mean ratios of the AUC0-inf parameter were calculated for each group. Relative bioavailability is reported as the geometric mean ratio, which was defined as the ratio of the geometric means for the dose-normalized AUC0-inf parameter (with and without body-weight adjustment) for the ravulizumab/rHuPH SC cohort divided by that for the ravulizumab SC cohort. | The PK Population included all participants who had sufficient serum concentration data to enable the calculation of PK parameters of at least AUC. For this outcome measure, the Number of Participants Analyzed includes the participants from both the ravulizumab/rHuPH SC cohort and the respective ravulizumab SC cohort. | Posted | Geometric Mean | 95% Confidence Interval | Percent bioavailability | Day 1 (after first dose) to Day 200 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Percent Change From Baseline (PCFB) In Serum Levels Of Total Complement Component 5 (C5) Concentrations | The highest (maximum difference) mean (standard deviation [SD]) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100. | The Pharmacodynamics (PD) Population included all participants who had sufficient free C5 concentration data that enabled the evaluation of the PD effects. | Posted | Mean | Standard Deviation | Percent change | Baseline, Up to Day 200 |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Maximum PCFB In Serum Levels Of Free C5 Concentrations | The highest (maximum difference) mean (SD) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100. | The PD Population included all participants who had sufficient free C5 concentration data that enabled the evaluation of the PD effects. | Posted | Mean | Standard Deviation | Percent Change | Baseline, Day 200 |
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| Secondary | Maximum PCFB In Ex Vivo Chicken Red Blood Cell (cRBC) Hemolysis Activity | The highest (maximum difference) mean (SD) PCFB at up to Day 200 is reported. Baseline was defined as the last available value prior to the first drug administration. Change from Baseline was calculated as observed value minus the baseline value. PCFB was calculated as change from baseline divided by baseline multiplied by 100. | The PD Population included all participants who had sufficient free C5 concentration data that enabled the evaluation of the PD effects. | Posted | Mean | Standard Deviation | Percent change | Baseline, Up to Day 200 |
|
Day 1 (after first dose) up to Day 200 (including safety follow up)
The Safety Population included all participants who receive at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1 | Participants received a single dose of ravulizumab 400 mg subcutaneously | 0 | 7 | 0 | 7 | 7 | 7 |
| EG001 | Cohort 2 | Participants received a single dose of ravulizumab 500 mg/rHuPH20 10000 units subcutaneously. | 0 | 12 | 0 | 12 | 11 | 12 |
| EG002 | Cohort 3 | Participants received a single dose of ravulizumab 1000 mg/rHuPH20 20000 units subcutaneously. | 0 | 12 | 0 | 12 | 12 | 12 |
| EG003 | Cohort 4 | Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously. | 0 | 12 | 0 | 12 | 10 | 12 |
| EG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. | 0 | 6 | 0 | 6 | 5 | 6 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza like illness | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Injection site paraesthesia | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment | The N for this adverse event has been adjusted to the number of females in the study as it is a sex-specific event. |
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| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Lethargy | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Hangover | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Bacterial vaginosis | Infections and infestations | MedDRA 21.0 | Systematic Assessment | The N for this adverse event has been adjusted to the number of females in the study as it is a sex-specific event. |
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| Laryngitis viral | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Respiratory tract infections | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Viral pharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
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| Feeling of body temperature change | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site discomfort | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Injection site reaction | General disorders | MedDRA 21.0 | Systematic Assessment |
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| Medical device site pruritus | General disorders | MedDRA 21.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
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| Muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Pharyngeal disorder | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Food poisoning | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Gingival bleeding | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Mucous stools | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Tongue discomfort | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Skin hypopigmentation | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Muscle strain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Vascular access site pain | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Mood swings | Psychiatric disorders | MedDRA 21.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Urine abnormality | Renal and urinary disorders | MedDRA 21.0 | Systematic Assessment |
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| Vaginal cyst | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment | The N for this adverse event has been adjusted to the number of females in the study as it is a sex-specific event. |
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| Vaginal discharge | Reproductive system and breast disorders | MedDRA 21.0 | Systematic Assessment | The N for this adverse event has been adjusted to the number of females in the study as it is a sex-specific event. |
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| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 21.0 | Systematic Assessment |
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| Ear pain | Ear and labyrinth disorders | MedDRA 21.0 | Systematic Assessment |
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| Allergy to animal | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
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| Menstruation normal | Investigations | MedDRA 21.0 | Systematic Assessment | The N for this adverse event has been adjusted to the number of females in the study as it is a sex-specific event. |
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| Tooth extraction | Surgical and medical procedures | MedDRA 21.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexion Pharmaceuticals, Inc. | Alexion Pharmaceuticals, Inc. | +1.855.752.2356 | clinicaltrials@alexion.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 25, 2019 | Jun 23, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| C000629409 | ravulizumab |
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Not provided
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| Preterm newborn infants (gestational age < 37 wks) |
|
| Newborns (0-27 days) |
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| Infants and toddlers (28 days-23 months) |
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| Children (2-11 years) |
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| Adolescents (12-17 years) |
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| Adults (18-64 years) |
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| From 65-84 years |
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| 85 years and over |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
|
| Black or African American |
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| White |
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| Other |
|
| Body weight-adjusted and dose-normalized AUC0-inf |
|
| OG003 | Cohort 4 | Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously. |
| OG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. |
|
|
| Cohort 4 |
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously. |
|
|
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously. |
| OG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. |
|
|
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
| OG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. |
|
|
Participants received a single dose of ravulizumab 2000 mg/rHuPH20 40000 units subcutaneously.
| OG004 | Cohort 5 | Participants received a single dose of ravulizumab 400 mg intravenously. |
|
|