← Back to Search

Monoclonal Antibodies

PRA023 SC for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 14 weeks
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and works in healthy people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 14 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cmax in Japanese subjects
F% in Caucasian subjects
Incidence, severity, causal relationship of treatment emergent adverse events
+1 more
Secondary outcome measures
Change in sTL1A levels
Cmax in Caucasian subjects
Immunogenicity rate
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Placebo SC/PRA023 IV High DoseExperimental Treatment2 Interventions
Group II: PRA023 SC/Placebo IVExperimental Treatment2 Interventions
Participants randomized to receive active subcutaneous injection/placebo intravenous infusion
Group III: Placebo SC/PRA023 IV Low DoseActive Control2 Interventions
Participants randomized to receive placebo subcutaneous injection/active intravenous infusion
Group IV: Placebo SC/Placebo IVPlacebo Group2 Interventions
Participants randomized to receive placebo subcutaneous injection/placebo intravenous infusion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo IV
2015
Completed Phase 4
~6100
PRA023 IV High Dose
2022
Completed Phase 1
~50
Placebo SC
2015
Completed Phase 4
~5410
PRA023 SC
2022
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
5 Previous Clinical Trials
550 Total Patients Enrolled
Altasciences Company Inc.Industry Sponsor
11 Previous Clinical Trials
398 Total Patients Enrolled
Prometheus Biosciences, Inc.Lead Sponsor
5 Previous Clinical Trials
550 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
2022. "Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05354349.
~16 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top