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NCT03542435 · ClinicalTrials.gov registry record · Phase 1
Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023
A Phase 1 study, sponsored by Promentis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT03542435: Completed Phase 1 study, sponsored by Promentis Pharmaceuticals.
NCT03542435 is a Phase 1 study that has completed, run by Promentis Pharmaceuticals. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03542435, a Phase 1 study, has completed, sponsored by Promentis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multiple ascending dose 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 following multiple ascending doses
Interventions
- DRUG Placebo
- DRUG SXC-2023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2018-04-26 |
| Est. Completion | 2018-09-10 |
| Phase | Phase 1 |
What the finished NCT03542435 record still lists
NCT03542435 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03542435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03542435 about?
NCT03542435 is a clinical study titled "Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023". This is a randomized, double-blind, placebo-controlled, multiple ascending dose 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 asse...
What is the current status of trial NCT03542435?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2018-04-26. Estimated completion is 2018-09-10.
What interventions are being tested in trial NCT03542435?
The interventions under investigation include: Placebo (DRUG), SXC-2023 (DRUG).
Who is sponsoring clinical trial NCT03542435?
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 NCT03542435's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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