A Study of PRA023 in Healthy Volunteers

A Phase 1, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetics Study of PRA023 in Healthy Volunteers

This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Placebo; Drug: PRA023

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 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:

  1. hysteroscopic sterilization;
  2. bilateral tubal ligation or bilateral salpingectomy;
  3. hysterectomy;
  4. bilateral oophorectomy, or;
  5. 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 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, 60-90 mmHg 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 >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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAD Cohorts 1-6 Experimental Arm; Subjects will receive single intravenous doses of PRA023 in a dose escalation format	Drug: PRA023; PRA023
Placebo Comparator: SAD Cohorts 1-6 Placebo Arm; Subjects will receive intravenous doses of placebo	Other: Placebo; Placebo
Experimental: MAD Cohorts 1-5 Experimental Arm; Subjects will receive three intravenous doses of PRA023, one dose every 2 weeks, in a dose escalation format	Drug: PRA023; PRA023
Placebo Comparator: MAD Cohorts 1-5 Placebo Arm; Subjects will receive three intravenous doses of placebo, one dose every 2 weeks,	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment emergent adverse events	Incidence, severity, and causal relationship of TEAEs	Up to 22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum concentration after single and multiple ascending doses	Up to 22 weeks
Tmax	Time to reach maximum concentration after single and multiple ascending doses	Up to 22 weeks
t1/2	Half life after single and multiple ascending doses	Up to 22 weeks
AUC	Area under the curve after single and multiple ascending doses	Up to 22 weeks
ADA	Incidence of anti-drug antibody after single and multiple ascending doses	Up to 22 weeks

Collaborators and Investigators

• Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Collaborators: Celerion
• Investigators: Study Chair: Allison Luo, MD, Prometheus Biosciences

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2020
• Primary Completion (Actual): September 23, 2021
• Study Completion (Actual): September 23, 2021

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: December 15, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PR200-101; 7240-003 (Other Identifier: Merck)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No