Trials / Recruiting
RecruitingNCT06864884
A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Arcato Laboratories, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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: 1. How much of the investigational product is absorbed in the blood? 2. Are there side effects?
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ARC-001 | Gel formulation containing investigational anesthetic. |
| DRUG | Placebo gel | Gel that contains no active ingredients. |
Timeline
- Start date
- 2025-02-26
- Primary completion
- 2026-02-01
- Completion
- 2026-02-01
- First posted
- 2025-03-07
- Last updated
- 2025-03-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06864884. Inclusion in this directory is not an endorsement.