MAD Cohorts 1-5 Experimental Arm for Healthy Subjects

Prometheus Clinical Site, Lincoln, NE
Healthy SubjectsPRA052 - Drug
Eligibility
18 - 60
All Sexes

Study Summary

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

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 20 weeks

Up to 20 weeks
ADA
Cmax
F%
Tmax
Therapeutic procedure
t1/2

Trial Safety

Trial Design

4 Treatment Groups

MAD Cohorts 1-5 Experimental Arm
1 of 4
SAD Cohorts 1-8 Experimental Arm
1 of 4
MAD Cohorts 1-5 Placebo Arm
1 of 4
SAD Cohorts 1-8 Placebo Arm
1 of 4

Experimental Treatment

Non-Treatment Group

104 Total Participants · 4 Treatment Groups

Primary Treatment: MAD Cohorts 1-5 Experimental Arm · Has Placebo Group · Phase 1

MAD Cohorts 1-5 Experimental Arm
Drug
Experimental Group · 1 Intervention: PRA052 · Intervention Types: Drug
SAD Cohorts 1-8 Experimental Arm
Drug
Experimental Group · 1 Intervention: PRA052 · Intervention Types: Drug
MAD Cohorts 1-5 Placebo Arm
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
SAD Cohorts 1-8 Placebo Arm
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 20 weeks

Who is running the clinical trial?

Prometheus Biosciences, Inc.Lead Sponsor
5 Previous Clinical Trials
438 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Nebraska100.0%
What site did they apply to?
Prometheus Clinical Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I like to help when possible."
What questions have other patients asked about this trial?
  • "What are the trial dates? Location? How much time at each appointment? Pay?"
How many prior treatments have patients received?
0100.0%

How responsive is this trial?

Most responsive sites:
  1. Prometheus Clinical Site: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.