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Bioavailability of SC Formulation and Japanese Ethnobridging Study for PRA023
NCT05354349 · View on ClinicalTrials.gov ↗
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)3 total trials
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 49 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05354349 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
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 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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