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NCT05354349 · ClinicalTrials.gov registry record · Phase 1
Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
A Phase 1 study of Healthy, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 1
- Development phase
- 49
- Enrollment target
- 1
- Study location
NCT05354349 is a Phase 1 study of Healthy that has completed, run by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 49 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05354349, a Phase 1 study of Healthy, has completed, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 49 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Placebo IV
- DRUG Placebo SC
- DRUG PRA023 IV Low Dose
- DRUG PRA023 SC
- DRUG PRA023 IV High Dose
Study Locations (1)
California
- Altasciences Clinical LA, Inc. - Cypress
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2022-04-06 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 1 |
Sponsor
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)6 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05354349
The ClinicalTrials.gov registry entry for NCT05354349 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower). The listed sponsor is Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 5 interventions - of which Placebo IV is the first listed.
NCT05354349 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05354349 about?
NCT05354349 is a clinical study titled "Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023". 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
What is the current status of trial NCT05354349?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 49 participants. The study started on 2022-04-06. Estimated completion is 2022-08-31.
What conditions does trial NCT05354349 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT05354349?
The interventions under investigation include: Placebo IV (DRUG), Placebo SC (DRUG), PRA023 IV Low Dose (DRUG), PRA023 SC (DRUG), PRA023 IV High Dose (DRUG).
Who is sponsoring clinical trial NCT05354349?
This trial is sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05354349 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.