Hereditary Angioedema Types I and II

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

NCT01760343 | PHASE 1 | INTERVENTIONAL

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.

1 Sites

16 Participants

Recruiting

18 Years to 45 Years

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SUBMIT

Study Site

Berlin,Germany

Study 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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov