Clinical trial NCT01760343: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hereditary Angioedema Types I and II
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
timeFrame: From the start of infusion to 24 hours after the end of infusion
Secondary outcomes:
measure: Incidence of adverse events (AEs) within 10 days of the CSL830 infusion
timeFrame: From the start of infusion to 10 days after the infusion
measure: Relative bioavailability of CSL830 versus Berinert - Cmax
timeFrame: 240 hours
measure: Relative bioavailability of CSL830 versus Berinert - AUC
timeFrame: 240 hours
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Study Site
Study officials:
affiliation: CSL Behring
name: Global Clinical Program Director
role: STUDY_DIRECTOR
References: