Hereditary Angioedema
Conditions
Interventions
There are 4 treatments in this study: Treatment A, B, C, and D. The volunteer
will receive 2 of them: either A and B or C and D. Which treatments the
volunteer will receive, and the order in which h
Sponsors
Pharvaris Netherlands BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject must sign an ICF indicating that the subject understands the purpose of the study including the procedures required, potential risks involved, and is willing to participate in the study before starting any screening activities. 2. Adult male or female subjects, between 18 to 65 years of age (inclusive) at the time of informed consent. 3. Subject must have a body mass index (BMI) between 18.0 and 35.0 kg/m2 (inclusive), and a body weight not less than 50.0 kg, inclusive, at screening. 4. A subject may be enrolled if she/he is willing and able to adhere to the contraceptive requirement as specified 5. All female subjects must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening and on Day -1 of each treatment period. 6. Subject must be willing and able to adhere to the prohibitions and restrictions as specified 7. Subject must be healthy on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality at screening per Investigator discretion.
Exclusion criteria
Exclusion criteria: 1. Subject has a history of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (estimated creatinine clearance 1.1 x upper limit of normal range [ULN]); - Hemoglobin below lower limit of normal range (LLN) (reference of site ); - Platelet count below LLN; - Absolute neutrophil count lowering grade 1 or greater ( ULN; - Total bilirubin > ULN; - Any other toxicity grade 2 or above, except for grade 2 elevations for triglycerides, low density lipoprotein (LDL) cholesterol and/or total cholesterol. 3. Subject underwent surgery or has a medical condition that might significantly affect absorption of medicines (e.g., stomach bypass, cholecystectomy, etc.) as judged by the Investigator. 4. Subject has clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the clinical site on Day -1 as judged by the Investigator. 5. Subject, at screening, has a positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. ECGs 2. vital sign measurements 3. PK blood sampling for PHA-022121 and its metabolites (PK blood sampling should be kept as close as possible to the specified time points.) 4. safety laboratory samples | — |
Countries
Netherlands
Outcome results
None listed