A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
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.
30 participants
Feb 26, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- Able to provide informed consent
- In generally good health
- BMI 18 to 38kg/m²
- Scheduled to undergo wisdom teeth extraction
Exclusion Criteria3
- Serious medical condition
- Clinically significant abnormal lab values
- Blood donation in the last 60 days, or plasma donation in the last 7 days.
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Interventions
Gel formulation containing investigational anesthetic.
Gel that contains no active ingredients.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06864884