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

Launched by ARCATO LABORATORIES, INC. · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new gel called ARC-001 to see if it can help manage pain after having wisdom teeth removed. The study is comparing this gel to a placebo, which means some participants will receive the gel while others will get a version without any active ingredients. The main goals of the trial are to find out how much of the gel gets absorbed into the bloodstream and to check for any side effects that might occur.

To be eligible for this trial, participants should be generally healthy, have a body mass index (BMI) between 18 and 38, and be scheduled for wisdom teeth extraction. People with serious medical conditions or certain lab test results are not eligible. If you decide to join, you'll receive the gel or the placebo after your surgery and will be monitored for any side effects. This study is currently recruiting participants aged 18 to 88, and it aims to ensure that the gel is safe and effective for managing post-operative pain.

Gender

ALL

Eligibility 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.