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

Conditions

• Acute Post Operative Pain
• Third Molar Extraction Surgery

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• ARC-001 — DRUG
  Gel formulation containing investigational anesthetic.
• Placebo gel — DRUG
  Gel that contains no active ingredients.

Study Details

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?

Key Dates

Start date

Feb 26, 2025

Status verified

Mar 2025

Primary completion

Feb 28, 2026

Completion

Feb 28, 2026

Study Design

Enrollment

30 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ARC-001
  0.75 mL gel emulsion with active ingredient applied once to the surgical site.
• Placebo Comparator: Placebo
  0.75 mL gel without active ingredient applied once to the surgical site.

Primary Outcome Measure

Safety and Tolerability [ Time Frame: 28 Days ]

Locations (1)

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