Status:
COMPLETED
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
Lead Sponsor:
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Collaborating Sponsors:
Altasciences Company Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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.
- Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days 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 administration.
Exclusion
- 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.
Key Trial Info
Start Date :
April 6 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2022
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT05354349
Start Date
April 6 2022
End Date
August 31 2022
Last Update
January 16 2024
Active Locations (1)
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1
Altasciences Clinical LA, Inc.
Cypress, California, United States, 90630