Status:
RECRUITING
A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
Lead Sponsor:
Arcato Laboratories, Inc.
Conditions:
Acute Post Operative Pain
Third Molar Extraction Surgery
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
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 an...
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.
Key Trial Info
Start Date :
February 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06864884
Start Date
February 26 2025
End Date
February 1 2026
Last Update
March 11 2025
Active Locations (1)
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1
CenExel JBR
Salt Lake City, Utah, United States, 84107