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

What this Trial Is About

Researchers are studying ARC-001, an investigational gel containing an anesthetic, to evaluate its safety and how much of it is absorbed into the blood after wisdom tooth extraction. This early phase 1 trial compares ARC-001 to a placebo gel that does not contain any active ingredients. The main goals are to assess safety, tolerability, and the gel's behavior in the body over 28 days. Participants will be randomly assigned to receive either 0.75 mL of ARC-001 gel or 0.75 mL of placebo gel applied once directly to the site of the wisdom tooth surgery. The trial is blinded and placebo-controlled, meaning neither participants nor researchers will know which gel is used during treatment. This helps ensure unbiased results regarding the gel's effects. During the 28-day study, participants will be monitored for any side effects and the amount of ARC-001 absorbed into the bloodstream. Safety and tolerability will be carefully observed through regular assessments and laboratory tests. Participation involves undergoing wisdom tooth extraction followed by application of the gel and attending follow-up visits for evaluation and monitoring throughout the study period.

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