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Monoclonal Antibodies

PRA052 for Healthy Volunteers

Phase 1
Waitlist Available
Research Sponsored by Prometheus Biosciences, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 20 weeks
Awards & highlights

Study Summary

This trial tests a new drug for safety, side effects, how it's absorbed and how it works in healthy people.

Who is the study for?
This trial is for healthy adult men and women (of non-childbearing potential) up to 60 years old. Participants must be in good health based on medical history, physical exams, chest x-rays, vital signs, ECGs, and lab tests. They should agree to use reliable contraception during the study.Check my eligibility
What is being tested?
The study is testing PRA052 against a placebo in healthy volunteers. It's designed to see how safe it is and how the body reacts to different doses over time. The process involves randomly assigning participants to receive either PRA052 or a placebo without knowing which one they're getting.See study design
What are the potential side effects?
Since this trial aims to determine the safety of PRA052, specific side effects are not yet known but will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between the legal adult age and 60, and cannot become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 20 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 20 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
Therapeutic procedure
Secondary outcome measures
ADA
Cmax
F%
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: SAD Cohorts 1-8 Experimental ArmExperimental Treatment1 Intervention
Subjects will receive a single intravenous or subcutaneous dose of PRA052 in a dose escalation format
Group II: MAD Cohorts 1-5 Experimental ArmExperimental Treatment1 Intervention
Subjects will receive three subcutaneous or intravenous doses of PRA052, one dose every 2 weeks, in a dose escalation format
Group III: MAD Cohorts 1-5 Placebo ArmPlacebo Group1 Intervention
Subjects will receive three subcutaneous or intravenous doses of placebo, one dose every 2 weeks
Group IV: SAD Cohorts 1-8 Placebo ArmPlacebo Group1 Intervention
Subjects will receive a single intravenous or subcutaneous dose of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PRA052
2022
Completed Phase 1
~100

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.Lead Sponsor
5 Previous Clinical Trials
503 Total Patients Enrolled
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)Lead Sponsor
5 Previous Clinical Trials
503 Total Patients Enrolled

Media Library

PRA052 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05603182 — Phase 1
Healthy Subjects Research Study Groups: SAD Cohorts 1-8 Experimental Arm, MAD Cohorts 1-5 Placebo Arm, MAD Cohorts 1-5 Experimental Arm, SAD Cohorts 1-8 Placebo Arm
Healthy Subjects Clinical Trial 2023: PRA052 Highlights & Side Effects. Trial Name: NCT05603182 — Phase 1
PRA052 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05603182 — Phase 1
Healthy Subjects Patient Testimony for trial: Trial Name: NCT05603182 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this medical experiment?

"This study is recruiting 104 adults aged 18 to 60 who meet the following requirements: Male or female (of non-fertile status) minimum of legal age according to local laws, males must practice reliable contraception during sexual intercourse with females from screening until 12 weeks after dosing. Furthermore, patients need to be in good health as assessed by medical history and examination reports such as chest X-ray, heart rate monitoring, electrocardiogram results and laboratory tests taken within a month prior to medication administration."

Answered by AI

How many patients have been recruited to participate in this research?

"Confirmed. Clinicaltrials.gov provides evidence that this experiment, first advertised on November 1st 2022, is still recruiting patients. The research requires a total of 104 volunteers to be gathered from one medical setting."

Answered by AI

Are recruitment efforts for this clinical trial still ongoing?

"According to clinicaltrials.gov, this medical study is actively searching for participants. The trial was first made public on November 1st 2022 and the most recent updates were added on November 3rd of the same year."

Answered by AI

Has the FDA approved SAD Cohorts 1-8's trial arm?

"As this is an early stage clinical trial, the safety rating for SAD Cohorts 1-8 Experimental Arm was conservatively assigned a value of 1 given limited evidence regarding their efficacy and security."

Answered by AI

Are elderly persons eligible for participation in this trial?

"As indicated by the terms of inclusion, only individuals between 18 and 60 years old will be allowed to partake in this medical trial."

Answered by AI

Who else is applying?

What state do they live in?
Nebraska
What site did they apply to?
Prometheus Clinical Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I like to help when possible.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

What are the trial dates? Location? How much time at each appointment? Pay?
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Prometheus Clinical Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study of PRA052 in Healthy Volunteers
2022. "A Study of PRA052 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05603182.
~40 spots leftby Apr 2025
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