Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04406415 · ClinicalTrials.gov registry record · Phase 1
Oral Nafamostat in Healthy Volunteers (NAF-101)
A Phase 1 study, sponsored by Ensysce Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
NCT04406415: Completed Phase 1 study, sponsored by Ensysce Biosciences.
NCT04406415 is a Phase 1 study that has completed, run by Ensysce Biosciences. The registered enrollment target is 17 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04406415, a Phase 1 study, has completed, sponsored by Ensysce Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects
Primary Outcome
Number of participants with adverse events including out-of-range clinical laboratory measures, vital signs, ECG, and spontaneous adverse event reports throughout the 14 day study period
Interventions
- DRUG Placebo
- DRUG Nafamostat Mesilate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2021-05-14 |
| Phase | Phase 1 |
What the finished NCT04406415 record still lists
NCT04406415 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04406415 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04406415 about?
NCT04406415 is a clinical study titled "Oral Nafamostat in Healthy Volunteers (NAF-101)". This is a randomized, double-blind, placebo-controlled Multiple Ascending Dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of oral nafamostat solution administered t.i.d.. for up to 5 days in healthy volunteer adult subjects
What is the current status of trial NCT04406415?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2020-09-21. Estimated completion is 2021-05-14.
What interventions are being tested in trial NCT04406415?
The interventions under investigation include: Placebo (DRUG), Nafamostat Mesilate (DRUG).
Who is sponsoring clinical trial NCT04406415?
This trial is sponsored by Ensysce Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04406415's enrollment target sits among peer trials
17 1785th of 2000 higher than 215 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02090140 · 17 participants · NA
Microfracture Versus Adipose Derived Stem Cells for the Treatment of Articular Cartilage Defects
- NCT03317860 · 17 participants · NA
Improving Measurement and Treatment of Post-stroke Neglect
- NCT04356469 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Non-Malignant Hematological Disorders in Children
- NCT04414046 · 17 participants · Phase 2
TCR Alpha Beta T-cell Depleted Haploidentical HCT in the Treatment of Primary Immunodeficiency and Inherited Metabolic Disorders in Children
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI