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A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
Sponsor: Arcato Laboratories, Inc.
Summary
The study will test the investigational product gel against placebo (which contains no active ingredient) to determine if it is safe after wisdom tooth extraction. The main questions the study will answer are: 1. How much of the investigational product is absorbed in the blood? 2. Are there side effects?
Official title: A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-02-26
Completion Date
2026-02
Last Updated
2025-03-11
Healthy Volunteers
No
Interventions
ARC-001
Gel formulation containing investigational anesthetic.
Placebo gel
Gel that contains no active ingredients.
Locations (1)
CenExel JBR
Salt Lake City, Utah, United States