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

Drug
ARC-001
Gel formulation containing investigational anesthetic.
Drug
Placebo gel
Gel that contains no active ingredients.

Location

CenExel JBR
Salt Lake City, Utah
participate@jbrutah.com 801-261-2000

A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction

Summary

Eligibility

Interventions

Location

Run this study?

Details

Conditions