A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorArcato Laboratories, Inc.
About this trial
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?
Eligibility criteria
Qualifiers
Able to provide informed consent
In generally good health
BMI 18 to 38kg/m²
Scheduled to undergo wisdom teeth extraction
Disqualifiers
Serious medical condition
Clinically significant abnormal lab values
Blood donation in the last 60 days, or plasma donation in the last 7 days.
Trial design
Treatments tested in this trial
- ARC-001
- Placebo gel
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov