A Phase 1, Safety and Pharmacokinetic Study of CSL312 in Healthy Subjects
- Conditions
- Hereditary AngioedemaHuman Genetics and Inherited Disorders - Other human genetics and inherited disordersInflammatory and Immune System - Other inflammatory or immune system disorders
- Registration Number
- ACTRN12616001438448
- Lead Sponsor
- CSL Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 48
Capable of providing written informed consent and willing and able to adhere to all protocol requirements.
- Male aged 18 to 45 years of age at the time of providing written informed consent.
- Judged as healthy by an investigator after completing a comprehensive clinical assessment (detailed medical history and complete physical examination).
- Body mass index (BMI) of 18.0 to less than 30.0 kg/m^2.
- Evidence of a clinically significant medical condition, disorder or disease including any of the following: hepatic (hepatitis, cirrhosis); biliary; renal; cardiac; bronchopulmonary; vascular; haematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic; psychiatric; immunodeficiency; cancer
- History of clinically significant arterial or venous thrombosis, bleeding disorder, or any abnormal coagulation test result at Screening (confirmed by repeat measurement)
- History of a severe allergic reaction with generalised urticaria; angioedema or anaphylaxis
- Abnormal clinical laboratory values and/or other study assessments, such as vital signs or ECG, deemed clinically significant by the investigator
- Positive serology test result for hepatitis B virus (HBV) surface antigen, human immunodeficiency virus (HIV) antibody, hepatitis A virus (HAV) antibody or hepatitis C virus (HCV) antibody at Screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method