Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: PRA023 SC; Drug: Placebo IV; Drug: PRA023 IV Low Dose; Drug: Placebo SC; Drug: PRA023 IV High Dose

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Cypress, California, United States, 90630
      • Altasciences Clinical LA, Inc.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Subjects are required to meet the following criteria in order to be included in the study:

  1. Japanese subjects must have both natural (not adopted) parents and four grandparents of Japanese origin.
  2. Caucasian subjects must be of European or Latin American descent (i.e., White).
  3. 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.

  4. 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.
  5. Male subjects must use reliable forms of contraception during sexual intercourse with female partners from screening to 30 days after the end of dosing.
  6. 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:

• Subjects with the following characteristics will be excluded from the study:

  1. 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.
  2. Blood pressure and heart rate are outside the ranges 90-140 mmHg systolic, 60-90mmHg diastolic, heart rate 60-100 beats/min.
  3. 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.
  4. 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.
  5. Any screening laboratory evaluation outside the laboratory reference range that is judged by the Investigator to be clinically significant.
  6. 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.
  7. History of significant allergy to any medication as judged by the Investigator.
  8. 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: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRA023 SC/Placebo IV; Participants randomized to receive active subcutaneous injection/placebo intravenous infusion	Drug: PRA023 SC; Drug; Drug: Placebo IV; Placebo
Active Comparator: Placebo SC/PRA023 IV Low Dose; Participants randomized to receive placebo subcutaneous injection/active intravenous infusion	Drug: PRA023 IV Low Dose; Drug; Drug: Placebo SC; Placebo
Placebo Comparator: Placebo SC/Placebo IV; Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion	Drug: Placebo IV; Placebo; Drug: Placebo SC; Placebo
Experimental: Placebo SC/PRA023 IV High Dose	Drug: Placebo SC; Placebo; Drug: PRA023 IV High Dose; Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence, severity, causal relationship of treatment emergent adverse events		Up to 14 Weeks
F% in Caucasian subjects	Mean SC versus IV AUC(inf) values	Up to 10 Weeks
Cmax in Japanese subjects	Maximum concentration after single dose	Up to 14 Weeks
Tmax in Japanese subjects	Time to reach maximum concentration after single dose	Up to 14 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax in Caucasian subjects	Maximum concentration after single dose	Up to 10 Weeks
Tmax in Caucasian subjects	Time to reach maximum concentration after single dose	Up to 10 Weeks
Immunogenicity rate		Up to 14 Weeks
Change in sTL1A levels		Up to 14 Weeks

Collaborators and Investigators

• Sponsor: Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Collaborators: Altasciences Company Inc.
• Investigators: Study Director: Prometheus Biosciences, Clinicaltrials Call Center

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: April 1, 2022
• First Submitted That Met QC Criteria: April 25, 2022
• First Posted (Actual): April 29, 2022

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 11, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: PR200-105; 7240-004 (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