← Back to all trials
Recruiting
NCT05603182
A Study of PRA052 in Healthy Volunteers
Conditions: Healthy
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 104
Sponsor: Prometheus Biosciences, Inc.
Location: United States
Summary
This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA052 in healthy volunteers.
Eligibility Criteria
Inclusion Criteria:Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 60 years of age.Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 12 weeks after the end of dosing.Good general health as determined by medical history, and by results of physical examination, chest x-ray, vital signs, ECG, and clinical laboratory tests obtained within 28 days (4 weeks) prior to study drug administrationExclusion Criteria:History or presence of any clinically significant organ system disease that could interfere with the objectives of the study or the safety of the subjects.Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 40-90 mmHg diastolic, heart rate 40-99 beats/min.12-lead ECG with any abnormality judged by the Investigator to be clinically significant, QRS >= 120 milliseconds (msec), or QTcF interval of > 450 msec for men or >470 msec for women.Presence or history of any abnormality or illness, which in the opinion of the Investigator may affect absorption, distribution, metabolism or elimination of the study drug.Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.History of or current active tuberculosis (TB) infection; history of latent TB that has not been fully treated or current latent TB infection as indicated by a positive QuantiFERON-TB test.History of significant allergy to any medication as judged by the Investigator.History of alcohol or drug abuse within the past 24 months.
Source: ClinicalTrials.gov (NCT05603182). StuddyBuddy aggregates publicly available trial information.