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

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Hereditary Angioedema Types I and II

Treatments: Biological: CSL830; Biological: Berinert

Study type: Interventional

Funder types: Industry

Identifiers

NCT01760343

2012-002429-31 (EudraCT Number)

CSL830_1001

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

Berinert, then CSL830

Experimental group

Description:

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

Treatment:

Biological: CSL830

Biological: Berinert

CSL830, then Berinert

Experimental group

Description:

A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.

Treatment:

Biological: CSL830

Biological: Berinert