A randomized, double-blind, placebo-controlled, single ascending dose study to examine the safety, tolerability and pharmacokinetics of orally administered PHA-022121 in healthy subjects.
- Conditions
- 10027664Hereditary Angioedema (HAE)
- Registration Number
- NL-OMON49665
- Lead Sponsor
- Pharvaris B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 32
Healthy male and female subjects of non-childbearing potential.
Between 18 and 65 years of age, inclusive.
Body mass index (BMI) between 18.0 and 30.0 kg/m2 (inclusive).
Healthy on the basis of physical examination, medical history, vital signs,
clinical laboratory tests, and 12-lead ECG performed at screening. If any of
the results are abnormal, the subject may be included only if the investigator
judges that the abnormalities or deviations from normal are not clinically
significant. This determination must be recorded in the subject's source
documents and initialled by the investigator.
A resting heart/pulse rate (supine position for 5 minutes) between 40 and 100
beats per minute (bpm). If heart/pulse rate is out of range, up to 2 repeated
assessments are permitted.
A resting blood pressure (supine position for 5 minutes) between 90 and 140
mmHg systolic, inclusive, and between 40 to 90 mmHg diastolic. If blood
pressure requirements are out of range, up to 2 repeated assessments are
permitted.
Clinically relevant allergy (except for untreated, asymptomatic, seasonal
allergies at time of dosing) or drug hypersensitivity.
Known hypersensitivity to the drug substance, or any inactive ingredient(s) of
the investigational product (refer to investigator's brochure).
History of any medical condition or prior surgery of the GI-tract that could
alter the absorption of orally administered drugs (does not apply to history of
appendectomy).
History or current evidence of any form of angioedema.
History or current evidence of any form of bronchial asthma.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoints:<br /><br><br /><br>Primary endpoint, safety:<br /><br>All standard safety assessments including physical examination, vital signs,<br /><br>adverse events, hematology, chemistry, urinalysis and ECG.<br /><br><br /><br>Primary endpoint, pharmacokinetics:<br /><br>Plasma PK parameters tmax, Cmax, AUC0-12h, AUC0-24h, AUClast, AUCinf, t1/2,<br /><br>CL/F and Vz/F of PHA-022121.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Plasma PK parameters tmax, Cmax, AUC0-12h, AUC0-24h, AUClast, AUCinf, and t1/2,<br /><br>of the major metabolite M2-D.<br /><br>QT, and the heart rate-corrected QT interval by Fridericia*s formula (QTcF) </p><br>