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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: Completed Phase 1 study of Healthy, sponsored by Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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. According to ClinicalTrials.gov, the official US trial registry.
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
What the finished NCT05354349 record still lists
NCT05354349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 49 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (92% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05354349's enrollment target sits among peer trials
49 474th of 1090 higher than 613 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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