Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023

NCT05354349 | Completed Phase 1 FDA Drug

• 2 other identifiers: PR200-1057240-004
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Cmax in Caucasian subjects

  Up to 10 Weeks

• Tmax in Caucasian subjects

  Up to 10 Weeks

• Immunogenicity rate

  Up to 14 Weeks

• Change in sTL1A levels

  Up to 14 Weeks

Study Arms (4)

PRA023 SC/Placebo IV

EXPERIMENTAL

Participants randomized to receive active subcutaneous injection/placebo intravenous infusion

Drug: PRA023 SC; Drug: Placebo IV

Placebo SC/PRA023 IV Low Dose

ACTIVE COMPARATOR

Participants randomized to receive placebo subcutaneous injection/active intravenous infusion

Drug: PRA023 IV Low Dose; Drug: Placebo SC

Placebo SC/Placebo IV

PLACEBO COMPARATOR

Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion

Drug: Placebo IV; Drug: Placebo SC

Placebo SC/PRA023 IV High Dose

EXPERIMENTAL

Drug: Placebo SC; Drug: PRA023 IV High Dose

Interventions

PRA023 IV Low Dose DRUG

Drug

Placebo SC/PRA023 IV Low Dose

PRA023 SC DRUG

Drug

PRA023 SC/Placebo IV

Placebo IV DRUG

Placebo

PRA023 SC/Placebo IV; Placebo SC/Placebo IV

Placebo SC DRUG

Placebo

Placebo SC/PRA023 IV High Dose; Placebo SC/PRA023 IV Low Dose; Placebo SC/Placebo IV

PRA023 IV High Dose DRUG

Drug

Placebo SC/PRA023 IV High Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA): lead
• Altasciences Company Inc.: collaborator

Study Sites (1)

Altasciences Clinical LA, Inc.

Cypress, California, 90630, United States

Location

Related Links

• Merck Clinical Trials Information

Study Officials

• Prometheus Biosciences

  Clinicaltrials Call Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: April 29, 2022
• Study Start: April 6, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)