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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

Who can join

Ages 18 to 55 · All sexes

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.

About the study

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?

What is being tested

• ARC-001 (drug)
• Placebo gel (drug)

Sponsor: Arcato Laboratories, Inc. · Participants: 30 · Started: Feb 26, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06864884

Locations in the U.S.

Conditions

• Pain After Surgery

From ClinicalTrials.gov, data retrieved Oct 1, 2026. Each study sets its own eligibility; the study team decides who can join.