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NCT03301298 · ClinicalTrials.gov registry record · Phase 1
Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers
A Phase 1 study, sponsored by Promentis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT03301298: Completed Phase 1 study, sponsored by Promentis Pharmaceuticals.
NCT03301298 is a Phase 1 study that has completed, run by Promentis Pharmaceuticals. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03301298, a Phase 1 study, has completed, sponsored by Promentis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and pharmacokinetic assessment of SXC-2023.
Primary Outcome
Treatment related adverse events as a measure of safety and tolerability of SXC-2023. Measured by patient reporting, assessment of vital signs and laboratory assessments.
Interventions
- DRUG Placebo oral capsule
- DRUG SXC-2023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2017-09-11 |
| Est. Completion | 2018-02-13 |
| Phase | Phase 1 |
What the finished NCT03301298 record still lists
NCT03301298 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03301298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03301298 about?
NCT03301298 is a clinical study titled "Placebo-Controlled Single Dose Study to Evaluate Safety and Pharmacokinetics of SXC-2023 in Healthy Volunteers". This is a randomized, double-blind, placebo-controlled, single ascending oral dose and food effect study conducted at one study center in the United States. Safety and tolerability will be assessed throughout the study and serial blood samples and urine samples will be collected for the safety and p...
What is the current status of trial NCT03301298?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2017-09-11. Estimated completion is 2018-02-13.
What interventions are being tested in trial NCT03301298?
The interventions under investigation include: Placebo oral capsule (DRUG), SXC-2023 (DRUG).
Who is sponsoring clinical trial NCT03301298?
This trial is sponsored by Promentis Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03301298's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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