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A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

Primary Purpose

Hereditary Angioedema Types I and II

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Berinert

CSL830

About this trial

This is an interventional treatment trial for Hereditary Angioedema Types I and II

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects without clinically significant medical conditions or laboratory abnormalities
Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent
Non-smokers
Body mass index of 18.0 to 29.0 kg/m2 inclusive

Exclusion Criteria:

Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.
Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.
Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.
Alcohol, drug, or medication abuse within one year before the study.
Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.

Sites / Locations

Study Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Berinert, then CSL830

CSL830, then Berinert

Arm Description

A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.

A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs) within 24 hours of CSL830 infusion

Secondary Outcome Measures

Incidence of adverse events (AEs) within 10 days of the CSL830 infusion

Relative bioavailability of CSL830 versus Berinert - Cmax

Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert

Relative bioavailability of CSL830 versus Berinert - AUC

Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert

Full Information

NCT ID

NCT01760343

First Posted

December 24, 2012

Last Updated

April 4, 2013

Sponsor

CSL Behring

1. Study Identification

Unique Protocol Identification Number

NCT01760343

Brief Title

A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

Official Title

A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CSL Behring

4. Oversight

5. Study Description

Brief Summary

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hereditary Angioedema Types I and II

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Berinert, then CSL830

Arm Type

Experimental

Arm Description

A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.

Arm Title

CSL830, then Berinert

Arm Type

Experimental

Arm Description

A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.

Intervention Type

Biological

Intervention Name(s)

Berinert

Intervention Description

Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.

Intervention Type

Biological

Intervention Name(s)

CSL830

Intervention Description

CSL830 is a formulation of Berinert.

Primary Outcome Measure Information:

Title

Incidence of adverse events (AEs) within 24 hours of CSL830 infusion

Time Frame

From the start of infusion to 24 hours after the end of infusion

Secondary Outcome Measure Information:

Title

Incidence of adverse events (AEs) within 10 days of the CSL830 infusion

Time Frame

From the start of infusion to 10 days after the infusion

Title

Relative bioavailability of CSL830 versus Berinert - Cmax

Description

Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert

Time Frame

240 hours

Title

Relative bioavailability of CSL830 versus Berinert - AUC

Description

Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert

Time Frame

240 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects without clinically significant medical conditions or laboratory abnormalities Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent Non-smokers Body mass index of 18.0 to 29.0 kg/m2 inclusive Exclusion Criteria: Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit. Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP. Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit. Alcohol, drug, or medication abuse within one year before the study. Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile. Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Program Director

Organizational Affiliation

CSL Behring

Official's Role

Study Director

Facility Information:

Facility Name

Study Site

City

Berlin

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

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