A Phase 1, Double-Blind, Placebo-Controlled, Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRA023 in Healthy Caucasian and Japanese Adult Volunteers

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)1 site in 1 country49 target enrollmentApril 6, 2022

ConditionsHealthy

InterventionsPRA023 IV High Dose Placebo SC PRA023 SC Placebo IV PRA023 IV Low Dose

DrugsPRA023 IV Low Dose PRA023 SC Placebo IV Placebo SC PRA023 IV High Dose

Overview

Phase: Phase 1
Intervention: PRA023 IV High Dose
Conditions: Healthy
Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Enrollment: 49
Locations: 1
Primary Endpoint: F% in Caucasian subjects
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, and pharmacokinetics of PRA023 in healthy Caucasian and Japanese adult volunteers

Registry

clinicaltrials.gov

Start Date

April 6, 2022

End Date

August 31, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects are required to meet the following criteria in order to be included in the study:
•Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin.
•Caucasian subjects must be of European or Latin American descent (i.e., White).
•Male or female (of non-childbearing potential only) between minimum adult legal age (according to local laws for signing the informed consent document) and 55 years of age.
•Females must be of non-childbearing potential and must have undergone one of the following sterilization procedures, and have official documentation, at least 6 months prior to the first dose:
•hysteroscopic sterilization;
•bilateral tubal ligation or bilateral salpingectomy;
•hysterectomy;
•bilateral oophorectomy, or;
•be postmenopausal with amenorrhea for at least 1 year prior to the first dose and have FSH serum levels consistent with postmenopausal status as per Investigator judgment.

Exclusion Criteria

•Subjects with the following characteristics will be excluded from the study:
•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, 60-90mmHg diastolic, heart rate 60-100 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 \> 470msec 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.