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

Description

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?

Conditions

Acute Post Operative Pain, Third Molar Extraction Surgery

Study Overview

Study Details

Study overview

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?

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

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

Condition
Acute Post Operative Pain
Intervention / Treatment

-

Contacts and Locations

Salt Lake City

CenExel JBR, Salt Lake City, Utah, United States, 84107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Able to provide informed consent
  • * In generally good health
  • * BMI 18 to 38kg/m²
  • * Scheduled to undergo wisdom teeth extraction
  • * Serious medical condition
  • * Clinically significant abnormal lab values
  • * Blood donation in the last 60 days, or plasma donation in the last 7 days.

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Arcato Laboratories, Inc.,

Study Record Dates

2026-02