NCT06864884EARLY_PHASE1Recruiting

A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction

Arcato Laboratories, Inc.

Start Date

2/26/2025

Completion Date

2/1/2026

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 Criteria

Age Range: 18 years to 55 years

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

DRUG

Placebo gel

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

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Conditions

Acute Post Operative PainThird Molar Extraction Surgery

Locations

CenExel JBR

Salt Lake City, Utah 84107

United States