Hereditary Angioedema
Conditions
Interventions
Part 1:
Subjects will be given PHA-022121 as a drink of 0.4 mL. Because of the small
volume, the drink will be administered via a syringe into the mouth. This will
be followed by drinking 240 millil
Sponsors
Pharvaris Netherlands BV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject must be a healthy male, between 18 to 65 years of age, extremes included, at screening. 2. Subject must have a body mass index (BMI; weight in kg divided by the square of height in meters) between 18.0 and 30.0 kg/m2, extremes included, and a body weight not less than 50.0 kg, inclusive, at screening. 3. Subject must sign an ICF indicating that he understands the purpose of the study including the procedures required, and is willing to participate in the study, including that he agrees to provide DNA samples for research, before starting of any screening activities. 4. During the study and for a minimum of 1 spermatogenesis cycle (defined as up to and including 90 days after receiving the study drug), a male subject may be enrolled if he is willing and able to adhere to the contraceptive requirement as specified in 4.5 item 12 in the protocol. 5. Subject must be willing and able to adhere to the prohibitions and restrictions. Further criteria apply.
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 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. Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at screening or at admission to the clinical site on Day -1 as deemed appropriate by the investigator. 4. Subject, at screening, has a positive test of human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies. 5. Subject has a history of heart arrhythmias , tachycardia at rest or history of risk factors for Torsade de Pointes syndrome (eg, hypokalemia, family history of long QT syndrome). Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: The primary objective of this study is to characterize the absorption, metabolism and excretion of orally administered radiolabeled PHA-022121 in healthy male subjects. Part 2: The primary objective is to determine the absolute bioavailability of orally administered PHA-022121 in healthy male subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: The secondary objective of this study is to evaluate safety and tolerability of a single oral dose of radiolabeled PHA-022121 administered in healthy male subjects. Part 2: The secondary objectives are - To evaluate the safety and tolerability of simultaneously administered unlabelled (orally) and radiolabeled (intravenously) PHA-022121 in healthy male subjects. - To determine the mass balance after an intravenously (IV) dose of a microdose/microtracer dose of PHA-022121. Optional after the results of study PHA022121-C003 and the mass balance data after IV dosing of a microdose/microtracer dose of PHA-022121 are available: - To characterize the metabolism of intravenously administered radiolabeled PHA-022121 in healthy male subjects. | — |
Countries
Netherlands
Outcome results
None listed