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

Phase 1

Completed

• Conditions: Hereditary Angioedema Types I and II
• Interventions: Biological: Berinert; Biological: CSL830

• Registration Number: NCT01760343
• Lead Sponsor: CSL Behring

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-24
• Study Start: 2013-01
• Study First Submitted QC: 2013-01-02
• Study First Posted: 2013-01-04
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-04
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) within 24 hours of CSL830 infusion	From the start of infusion to 24 hours after the end of infusion

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs) within 10 days of the CSL830 infusion	From the start of infusion to 10 days after the infusion
Relative bioavailability of CSL830 versus Berinert - Cmax	240 hours	Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert
Relative bioavailability of CSL830 versus Berinert - AUC	240 hours	Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert

Trial Locations

Locations (1)

Study Site; 🇩🇪 Berlin, Germany