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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

An Open-Label Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Versus Intravenous (IV) Administration of CINRYZE in Adolescents and Adults With Hereditary Angioedema (HAE)

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01095497
Enrollment
26
Registered
2010-03-30
Start date
2010-06-07
Completion date
2010-12-16
Last updated
2021-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary Angioedema

Keywords

HAE, C1 inhibitor (C1INH), Subcutaneous

Brief summary

The objectives of the study are to: 1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema 2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection 3. Assess the immunogenicity of CINRYZE following subcutaneous administration

Interventions

BIOLOGICALCINRYZE

C1 esterase inhibitor (human)

Sponsors

Shire
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No

Inclusion criteria

To be eligible for this protocol, a subject must: 1. Have a confirmed diagnosis of HAE. 2. During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) treated with C1INH therapy or any other blood products, ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (e.g., tranexamic acid), IV fluids, or narcotic analgesics. 3. Agree to strictly adhere to the protocol-defined schedule of assessments and procedures.

Exclusion criteria

To be eligible for this protocol, a subject must not: 1. Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose. 2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose. 3. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose. 4. If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose. 5. Have a history of abnormal blood clotting or other coagulopathy. 6. Have a history of allergic reaction to CINRYZE or other blood products. 7. Be pregnant or breastfeeding. 8. Have received an immunization within 30 days prior to the first dose. 9. Have participated in any other investigational drug study within 30 days prior to the first dose.

Design outcomes

Primary

MeasureTime frame
Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.18 days in each treatment period

Secondary

MeasureTime frameDescription
Mean Change C1 Inhibitor (C1INH)18 days in each treatment periodMean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Mean Change C4 Compliment18 days in each treatment periodMean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.
Number of Participants With C1 Inhibitor (INH) Antibodies18 days in each treatment period—

Countries

United States

Participant flow

Participants by arm

ArmCount
IV CINRYZE First, Then SC CINRYZE Dose 1
Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
14
IV CINRYZE First, Then SC CINRYZE Dose 2
Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
12
Total26

Baseline characteristics

CharacteristicIV CINRYZE First, Then SC CINRYZE Dose 1IV CINRYZE First, Then SC CINRYZE Dose 2Total
Age, Continuous28.6 years
STANDARD_DEVIATION 12.7
37.3 years
STANDARD_DEVIATION 15.92
32.7 years
STANDARD_DEVIATION 14.66
Sex: Female, Male
Female
7 Participants8 Participants15 Participants
Sex: Female, Male
Male
7 Participants4 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
8 / 2610 / 1311 / 12
serious
Total, serious adverse events
0 / 260 / 130 / 12

Outcome results

Primary

Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.

Time frame: 18 days in each treatment period

Population: Safety Analysis Set

ArmMeasureGroupValue (NUMBER)Dispersion
Intravenous (IV) CINRYZEIncidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects who withdrew from the study1 Participants—
Intravenous (IV) CINRYZEIncidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects who discontinued study drug1 Participants—
Intravenous (IV) CINRYZEIncidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects with adverse events12 Participants 0.019
Intravenous (IV) CINRYZEIncidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects with injection site reactions1 Participants 0.033
Subcutaneous (SC) CINRYZE Dose 1Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects who discontinued study drug0 Participants—
Subcutaneous (SC) CINRYZE Dose 1Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects with adverse events10 Participants 0.027
Subcutaneous (SC) CINRYZE Dose 1Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects with injection site reactions10 Participants 0.032
Subcutaneous (SC) CINRYZE Dose 1Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects who withdrew from the study1 Participants—
SC CINRYZE Dose 2Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects who discontinued study drug0 Participants—
SC CINRYZE Dose 2Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects with adverse events11 Participants 0.01
SC CINRYZE Dose 2Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects who withdrew from the study0 Participants—
SC CINRYZE Dose 2Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.Number of subjects with injection site reactions11 Participants 0.01
Secondary

Mean Change C1 Inhibitor (C1INH)

Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.

Time frame: 18 days in each treatment period

Population: Intent to Treat Population

ArmMeasureGroupValue (MEAN)Dispersion
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)2 h post Dose 10.070 g/LStandard Deviation 0.021
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)4 h post Dose 10.065 g/LStandard Deviation 0.022
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)6 h post Dose 10.064 g/LStandard Deviation 0.018
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)Pre-Dose 20.027 g/LStandard Deviation 0.024
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)1 h post Dose 20.088 g/LStandard Deviation 0.036
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)1 h post Dose 30.093 g/LStandard Deviation 0.028
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)2 h post Dose 40.092 g/LStandard Deviation 0.032
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)3 h post Dose 40.087 g/LStandard Deviation 0.031
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)72 h post Dose 40.025 g/LStandard Deviation 0.022
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)168 h post Dose 40.005 g/LStandard Deviation 0.016
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)1 hour (h) post Dose 10.075 g/LStandard Deviation 0.023
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)3 h post Dose 10.070 g/LStandard Deviation 0.023
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)8 h post Dose 10.062 g/LStandard Deviation 0.019
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)24 h post Dose 10.049 g/LStandard Deviation 0.016
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)48 h post Dose 10.035 g/LStandard Deviation 0.017
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)120 h post Dose 10.042 g/LStandard Deviation 0.018
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)Pre-Dose 30.019 g/LStandard Deviation 0.016
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)Pre-Dose 40.024 g/LStandard Deviation 0.02
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)1 h post Dose 40.098 g/LStandard Deviation 0.035
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)4 h post Dose 40.086 g/LStandard Deviation 0.031
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)6 h post Dose 40.081 g/LStandard Deviation 0.031
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)8 h post Dose 40.080 g/LStandard Deviation 0.029
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)24 h post Dose 40.060 g/LStandard Deviation 0.025
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)48 h post Dose 40.038 g/LStandard Deviation 0.022
Intravenous (IV) CINRYZEMean Change C1 Inhibitor (C1INH)120 h post Dose 40.008 g/LStandard Deviation 0.018
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)1 hour (h) post Dose 1-0.002 g/LStandard Deviation 0.008
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)3 h post Dose 1-0.002 g/LStandard Deviation 0.007
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)4 h post Dose 10.003 g/LStandard Deviation 0.005
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)6 h post Dose 10.002 g/LStandard Deviation 0.009
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)8 h post Dose 10.003 g/LStandard Deviation 0.01
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)8 h post Dose 40.017 g/LStandard Deviation 0.032
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)24 h post Dose 10.016 g/LStandard Deviation 0.023
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)48 h post Dose 10.019 g/LStandard Deviation 0.03
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)120 h post Dose 40.003 g/LStandard Deviation 0.022
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)120 h post Dose 10.024 g/LStandard Deviation 0.032
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)24 h post Dose 40.026 g/LStandard Deviation 0.032
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)Pre-Dose 30.012 g/LStandard Deviation 0.024
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)Pre-Dose 40.019 g/LStandard Deviation 0.034
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)2 h post Dose 1-0.002 g/LStandard Deviation 0.008
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)168 h post Dose 40.005 g/LStandard Deviation 0.024
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)1 h post Dose 40.010 g/LStandard Deviation 0.031
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)Pre-Dose 20.011 g/LStandard Deviation 0.021
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)3 h post Dose 40.014 g/LStandard Deviation 0.03
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)1 h post Dose 20.013 g/LStandard Deviation 0.022
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)1 h post Dose 30.012 g/LStandard Deviation 0.024
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)72 h post Dose 40.017 g/LStandard Deviation 0.026
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)2 h post Dose 40.012 g/LStandard Deviation 0.028
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)4 h post Dose 40.016 g/LStandard Deviation 0.029
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)48 h post Dose 40.022 g/LStandard Deviation 0.028
Subcutaneous (SC) CINRYZE Dose 1Mean Change C1 Inhibitor (C1INH)6 h post Dose 40.016 g/LStandard Deviation 0.028
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)48 h post Dose 40.045 g/LStandard Deviation 0.012
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)2 h post Dose 1-0.001 g/LStandard Deviation 0.004
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)6 h post Dose 40.034 g/LStandard Deviation 0.015
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)1 h post Dose 40.031 g/LStandard Deviation 0.012
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)3 h post Dose 1-0.002 g/LStandard Deviation 0.007
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)Pre-Dose 40.030 g/LStandard Deviation 0.015
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)6 h post Dose 10.006 g/LStandard Deviation 0.007
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)168 h post Dose 40.017 g/LStandard Deviation 0.011
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)4 h post Dose 10.003 g/LStandard Deviation 0.007
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)8 h post Dose 10.009 g/LStandard Deviation 0.008
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)4 h post Dose 40.035 g/LStandard Deviation 0.015
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)120 h post Dose 40.025 g/LStandard Deviation 0.012
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)24 h post Dose 10.021 g/LStandard Deviation 0.011
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)8 h post Dose 40.036 g/LStandard Deviation 0.012
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)2 h post Dose 40.029 g/LStandard Deviation 0.015
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)48 h post Dose 10.028 g/LStandard Deviation 0.009
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)1 h post Dose 20.027 g/LStandard Deviation 0.009
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)Pre-Dose 20.026 g/LStandard Deviation 0.008
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)72 h post Dose 40.037 g/LStandard Deviation 0.013
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)120 h post Dose 10.037 g/LStandard Deviation 0.009
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)1 hour (h) post Dose 1-0.001 g/LStandard Deviation 0.006
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)3 h post Dose 40.031 g/LStandard Deviation 0.014
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)Pre-Dose 30.024 g/LStandard Deviation 0.009
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)1 h post Dose 30.024 g/LStandard Deviation 0.01
SC CINRYZE Dose 2Mean Change C1 Inhibitor (C1INH)24 h post Dose 40.043 g/LStandard Deviation 0.009
Secondary

Mean Change C4 Compliment

Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.

Time frame: 18 days in each treatment period

Population: Intent to Treat Population

ArmMeasureGroupValue (MEAN)Dispersion
Intravenous (IV) CINRYZEMean Change C4 Compliment24 h post Dose 456.5 mg/LStandard Deviation 36
Intravenous (IV) CINRYZEMean Change C4 Compliment2 h post Dose 429.4 mg/LStandard Deviation 26.2
Intravenous (IV) CINRYZEMean Change C4 Compliment3 h post Dose 434.7 mg/LStandard Deviation 24.9
Intravenous (IV) CINRYZEMean Change C4 Compliment4 h post Dose 433.7 mg/LStandard Deviation 31.1
Intravenous (IV) CINRYZEMean Change C4 Compliment6 h post Dose 112.0 mg/LStandard Deviation 24.8
Intravenous (IV) CINRYZEMean Change C4 Compliment6 h post Dose 439.4 mg/LStandard Deviation 26.8
Intravenous (IV) CINRYZEMean Change C4 Compliment8 h post Dose 441.9 mg/LStandard Deviation 30.1
Intravenous (IV) CINRYZEMean Change C4 Compliment48 h post Dose 454.9 mg/LStandard Deviation 34.6
Intravenous (IV) CINRYZEMean Change C4 Compliment8 h post Dose 113.0 mg/LStandard Deviation 20.7
Intravenous (IV) CINRYZEMean Change C4 Compliment72 h post Dose 446.1 mg/LStandard Deviation 36.2
Intravenous (IV) CINRYZEMean Change C4 Compliment120 h post Dose 411.0 mg/LStandard Deviation 32.1
Intravenous (IV) CINRYZEMean Change C4 Compliment168 h post Dose 4-0.6 mg/LStandard Deviation 27.1
Intravenous (IV) CINRYZEMean Change C4 Compliment24 h post Dose 125.5 mg/LStandard Deviation 30.3
Intravenous (IV) CINRYZEMean Change C4 Compliment4 h post Dose 12.7 mg/LStandard Deviation 14.8
Intravenous (IV) CINRYZEMean Change C4 Compliment48 h post Dose 131.0 mg/LStandard Deviation 25.3
Intravenous (IV) CINRYZEMean Change C4 Compliment1 hour (h) post Dose 1-7.5 mg/LStandard Deviation 15.4
Intravenous (IV) CINRYZEMean Change C4 ComplimentPre-Dose 229.5 mg/LStandard Deviation 23.9
Intravenous (IV) CINRYZEMean Change C4 Compliment1 h post Dose 224.7 mg/LStandard Deviation 26.4
Intravenous (IV) CINRYZEMean Change C4 Compliment1 h post Dose 428.6 mg/LStandard Deviation 27
Intravenous (IV) CINRYZEMean Change C4 Compliment120 h post Dose 153.1 mg/LStandard Deviation 24.4
Intravenous (IV) CINRYZEMean Change C4 Compliment2 h post Dose 1-0.6 mg/LStandard Deviation 10.2
Intravenous (IV) CINRYZEMean Change C4 ComplimentPre-Dose 328.1 mg/LStandard Deviation 29.3
Intravenous (IV) CINRYZEMean Change C4 Compliment3 h post Dose 1-1.3 mg/LStandard Deviation 13.5
Intravenous (IV) CINRYZEMean Change C4 Compliment1 h post Dose 326.0 mg/LStandard Deviation 20.9
Intravenous (IV) CINRYZEMean Change C4 ComplimentPre-Dose 434.4 mg/LStandard Deviation 26.9
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment1 h post Dose 25.6 mg/LStandard Deviation 23.7
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment1 h post Dose 41.9 mg/LStandard Deviation 25
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment4 h post Dose 1-5.3 mg/LStandard Deviation 18.5
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment24 h post Dose 44.0 mg/LStandard Deviation 23.8
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment2 h post Dose 46.6 mg/LStandard Deviation 25.2
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment120 h post Dose 4-4.5 mg/LStandard Deviation 26
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment24 h post Dose 12.9 mg/LStandard Deviation 25.4
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 ComplimentPre-Dose 45.4 mg/LStandard Deviation 27.6
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment4 h post Dose 49.2 mg/LStandard Deviation 27
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment120 h post Dose 121.7 mg/LStandard Deviation 22.7
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment48 h post Dose 16.2 mg/LStandard Deviation 23.1
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment6 h post Dose 44.2 mg/LStandard Deviation 26.5
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment6 h post Dose 1-0.6 mg/LStandard Deviation 37.1
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment1 h post Dose 35.8 mg/LStandard Deviation 22.3
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment8 h post Dose 46.4 mg/LStandard Deviation 27.8
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment3 h post Dose 48.8 mg/LStandard Deviation 25
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment3 h post Dose 1-0.6 mg/LStandard Deviation 10.9
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment48 h post Dose 48.2 mg/LStandard Deviation 23.6
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 ComplimentPre-Dose 28.7 mg/LStandard Deviation 23.4
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment1 hour (h) post Dose 1-12.9 mg/LStandard Deviation 15.6
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment72 h post Dose 410.9 mg/LStandard Deviation 27.9
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment8 h post Dose 1-8.2 mg/LStandard Deviation 24.6
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 ComplimentPre-Dose 37.3 mg/LStandard Deviation 20.6
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment168 h post Dose 42.2 mg/LStandard Deviation 24.5
Subcutaneous (SC) CINRYZE Dose 1Mean Change C4 Compliment2 h post Dose 1-3.8 mg/LStandard Deviation 18.2
SC CINRYZE Dose 2Mean Change C4 Compliment168 h post Dose 436.5 mg/LStandard Deviation 32.9
SC CINRYZE Dose 2Mean Change C4 Compliment2 h post Dose 1-3.3 mg/LStandard Deviation 8.9
SC CINRYZE Dose 2Mean Change C4 Compliment3 h post Dose 454.9 mg/LStandard Deviation 26.4
SC CINRYZE Dose 2Mean Change C4 Compliment8 h post Dose 467.3 mg/LStandard Deviation 53.4
SC CINRYZE Dose 2Mean Change C4 Compliment120 h post Dose 447.2 mg/LStandard Deviation 32.3
SC CINRYZE Dose 2Mean Change C4 Compliment1 hour (h) post Dose 10.1 mg/LStandard Deviation 8
SC CINRYZE Dose 2Mean Change C4 Compliment3 h post Dose 12.5 mg/LStandard Deviation 11.1
SC CINRYZE Dose 2Mean Change C4 Compliment4 h post Dose 18.8 mg/LStandard Deviation 23.7
SC CINRYZE Dose 2Mean Change C4 Compliment6 h post Dose 18.1 mg/LStandard Deviation 21
SC CINRYZE Dose 2Mean Change C4 Compliment8 h post Dose 111.2 mg/LStandard Deviation 27.4
SC CINRYZE Dose 2Mean Change C4 Compliment24 h post Dose 114.3 mg/LStandard Deviation 12.7
SC CINRYZE Dose 2Mean Change C4 Compliment48 h post Dose 123.3 mg/LStandard Deviation 18
SC CINRYZE Dose 2Mean Change C4 ComplimentPre-Dose 230.2 mg/LStandard Deviation 15.3
SC CINRYZE Dose 2Mean Change C4 Compliment1 h post Dose 231.8 mg/LStandard Deviation 19.3
SC CINRYZE Dose 2Mean Change C4 Compliment120 h post Dose 137.9 mg/LStandard Deviation 28.1
SC CINRYZE Dose 2Mean Change C4 ComplimentPre-Dose 357.3 mg/LStandard Deviation 46.6
SC CINRYZE Dose 2Mean Change C4 Compliment1 h post Dose 340.4 mg/LStandard Deviation 26.5
SC CINRYZE Dose 2Mean Change C4 ComplimentPre-Dose 450.5 mg/LStandard Deviation 18.7
SC CINRYZE Dose 2Mean Change C4 Compliment1 h post Dose 451.2 mg/LStandard Deviation 22.6
SC CINRYZE Dose 2Mean Change C4 Compliment2 h post Dose 449.4 mg/LStandard Deviation 21.1
SC CINRYZE Dose 2Mean Change C4 Compliment4 h post Dose 462.8 mg/LStandard Deviation 41.2
SC CINRYZE Dose 2Mean Change C4 Compliment6 h post Dose 467.1 mg/LStandard Deviation 57.3
SC CINRYZE Dose 2Mean Change C4 Compliment24 h post Dose 449.3 mg/LStandard Deviation 31.6
SC CINRYZE Dose 2Mean Change C4 Compliment48 h post Dose 456.5 mg/LStandard Deviation 29.2
SC CINRYZE Dose 2Mean Change C4 Compliment72 h post Dose 462.6 mg/LStandard Deviation 43.8
Secondary

Number of Participants With C1 Inhibitor (INH) Antibodies

Time frame: 18 days in each treatment period

ArmMeasureValue (NUMBER)
Intravenous (IV) CINRYZENumber of Participants With C1 Inhibitor (INH) Antibodies0 Participants
Subcutaneous (SC) CINRYZE Dose 1Number of Participants With C1 Inhibitor (INH) Antibodies0 Participants
SC CINRYZE Dose 2Number of Participants With C1 Inhibitor (INH) Antibodies0 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026