RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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?

Official Title

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

Quick Facts

Study Start:2025-02-26
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06864884

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.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to provide informed consent
  2. * In generally good health
  3. * BMI 18 to 38kg/m²
  4. * Scheduled to undergo wisdom teeth extraction
  1. * Serious medical condition
  2. * Clinically significant abnormal lab values
  3. * Blood donation in the last 60 days, or plasma donation in the last 7 days.

Contacts and Locations

Study Locations (Sites)

CenExel JBR
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Arcato Laboratories, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-26
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-02-26
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • wisdom teeth surgery

Additional Relevant MeSH Terms

  • Acute Post Operative Pain
  • Third Molar Extraction Surgery