A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Safety and Tolerability
Study Overview
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 answer are:
- How much of the investigational product is absorbed in the blood?
- Are there side effects?
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ARC-001
0.75 mL gel emulsion with active ingredient applied once to the surgical site.
Intervention: ARC-001 (Drug)
Placebo
0.75 mL gel without active ingredient applied once to the surgical site.
Intervention: Placebo gel (Drug)
Outcomes
Primary Outcomes
Safety and Tolerability
Time Frame: 28 Days
To evaluate the safety and tolerability of ARC-001 Gel compared to placebo by comparing the incidence of oral treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through oral exam for soft tissue health using the modified Landry Index and evaluation of the presence or absence of dry socket.
Secondary Outcomes
No secondary outcomes reported