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NCT Number: NCT01760343

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

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.

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Key information

Conditions

Hereditary Angioedema Types I and II Angioedema Angioedemas, Hereditary Cardiovascular Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Study Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Berinert

Biological

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

CSL830

Biological

CSL830 is a formulation of Berinert.

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Relative bioavailability of CSL830 versus Berinert - Cmax

    Time frame: 240 hours

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

  3. Relative bioavailability of CSL830 versus Berinert - AUC

    Time frame: 240 hours

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

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jan 4, 2013
Registry last updated
Apr 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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