Study detail
RecruitingPhase 1
A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
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?
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Detailed criteria
Inclusion Criteria: * Able to provide informed consent * In generally good health * BMI 18 to 38kg/m² * Scheduled to undergo wisdom teeth extraction Exclusion Criteria: * Serious medical condition * Clinically significant abnormal lab values * Blood donation in the last 60 days, or plasma donation in the last 7 days.
Interventions
- DrugARC-001
Gel formulation containing investigational anesthetic.
- DrugPlacebo gel
Gel that contains no active ingredients.
Location
- CenExel JBRSalt Lake City, Utah