Hereditary Angioedema Types I and II
Conditions
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.
Interventions
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Germany
Outcome results
None listed