NCT04406415

Oral Nafamostat in Healthy Volunteers (NAF-101)

A Single-Center, Double-Blind, Placebo-Controlled, Phase 1b Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Sequential Dose Regimens of Oral Nafamostat Mesylate in Healthy Volunteers Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Ensysce Biosciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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

Detailed description

Subjects will undergo a medical screening (Days -1 to -10) and, if eligible, informed consent will be obtained prior to 6 days of confinement at the clinic site. Up to 20 subjects will be randomized. Subjects will be stratified to include an equal number of male and female subjects who will receive active drug within each dose cohort, and an equal number of male and female subjects in the combined placebo group. Separate groups of volunteers will be used for each dose cohort. There will be 4 dose cohorts in this study with active drug doses of 10, 50, 100, and 200 mg nafamostat in succeeding cohorts. Each cohort of 5 subjects will enroll 2 male and 2 female to receive active drug and 1 subject (male or female) to receive placebo for a total of 20 subjects. The placebo subject from each cohort will be combined into a placebo cohort that will have 4 subjects to compare to 4 subjects in each of the active dose groups.

Conditions

• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	Nafamostat Mesilate	Oral nafamostat, 10, 50, 100, or 200 mg administered three times daily for up to 5 days
DRUG	Placebo	Oral placebo administered three times daily for up to 5 days

Timeline

• Start date: 2020-09-21
• Primary completion: 2020-11-11
• Completion: 2021-05-14
• First posted: 2020-05-28
• Last updated: 2024-09-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study