PRA023 SC for Healthy Subjects (HS)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Altasciences Clinical LA, Inc., Cypress, CA
Healthy Subjects (HS)
PRA023 SC - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it is safe and works in healthy people. PRA023 SC is used to treat Healthy Subjects (HS) and has previously been approved by the FDA for a different condition. This treatment is free.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Healthy Subjects (HS)

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: Up to 14 Weeks

Up to 10 Weeks
Cmax in Caucasian subjects
F% in Caucasian subjects
Tmax in Caucasian subjects
Up to 14 Weeks
Change in sTL1A levels
Cmax in Japanese subjects
Immunogenicity rate
Incidence, severity, causal relationship of treatment emergent adverse events
Tmax in Japanese subjects

Trial Safety

Safety Progress

1 of 3

Other trials for Healthy Subjects (HS)

Trial Design

4 Treatment Groups

Placebo SC/PRA023 IV Low Dose
1 of 4
Placebo SC/PRA023 IV High Dose
1 of 4
PRA023 SC/Placebo IV
1 of 4
Placebo SC/Placebo IV
1 of 4
Active Control
Experimental Treatment
Non-Treatment Group

49 Total Participants · 4 Treatment Groups

Primary Treatment: PRA023 SC · Has Placebo Group · Phase 1

Placebo SC/PRA023 IV High DoseExperimental Group · 2 Interventions: Placebo SC, PRA023 IV High Dose · Intervention Types: Drug, Drug
PRA023 SC/Placebo IVExperimental Group · 2 Interventions: PRA023 SC, Placebo IV · Intervention Types: Drug, Drug
Placebo SC/Placebo IVPlaceboComparator Group · 2 Interventions: Placebo SC, Placebo IV · Intervention Types: Drug, Drug
Placebo SC/PRA023 IV Low DoseActiveComparator Group · 2 Interventions: Placebo SC, PRA023 IV Low Dose · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo SC
2015
Completed Phase 4
~4360
Placebo IV
2015
Completed Phase 4
~4980

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 14 weeks
Closest Location: Altasciences Clinical LA, Inc. · Cypress, CA
Photo of california 1Photo of california 2Photo of california 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Healthy Subjects (HS)
0 CompletedClinical Trials

Who is running the clinical trial?

Prometheus Biosciences, Inc.Lead Sponsor
4 Previous Clinical Trials
389 Total Patients Enrolled
1 Trials studying Healthy Subjects (HS)
69 Patients Enrolled for Healthy Subjects (HS)
altasciencesUNKNOWN
Prometheus BiosciencesStudy DirectorClinicaltrials Call Center
3 Previous Clinical Trials
320 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are of European or Latin American descent (i.e., White).
You are male or female, of non-childbearing potential, between 18 and 55 years of age.
You are 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.
You are of Japanese origin.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.