A Study of PRA052 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PRA052; Other: Placebo

• Registration Number: NCT05603182
• Lead Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-27
• Study First Submitted QC: 2022-10-27
• Study First Posted: 2022-11-02
• Study Start: 2022-11-07
• Primary Completion: 2024-02-21
• Study Completion: 2024-02-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-06
• Last Update Posted: 2024-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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 administration

Exclusion 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SAD Cohorts 1-8 Experimental Arm	PRA052	Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format
SAD Cohorts 1-8 Placebo Arm	Placebo	Subjects will receive a single intravenous or subcutaneous dose of placebo
MAD Cohorts 1-5 Placebo Arm	Placebo	Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks
MAD Cohorts 1-5 Experimental Arm	PRA052	Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format

Primary Outcome Measures

Name	Time	Method
Treatment emergent adverse events	Up to 20 weeks	Incidence, severity, and causal relationship of TEAEs

Secondary Outcome Measures

Name	Time	Method
t1/2	Up to 20 weeks	Half life after single and multiple ascending doses
Tmax	Up to 20 weeks	Time to reach maximum concentration after single and multiple ascending doses
Cmax	Up to 20 weeks	Maximum concentration after single and multiple ascending doses
F%	Up to 20 weeks	Bioavailability after SC injection
ADA	Up to 20 weeks	Incidence of anti-drug antibody after single and multiple ascending doses

Trial Locations

Locations (1)

Prometheus Clinical Site; 🇺🇸 Lincoln, Nebraska, United States