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

NCT06864884 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-03-11

No results posted yet for this study

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

  • Acute Post Operative Pain
  • Third Molar Extraction Surgery

Interventions

DRUG

ARC-001

Gel formulation containing investigational anesthetic.

DRUG

Placebo gel

Gel that contains no active ingredients.

Sponsors & Collaborators

  • Arcato Laboratories, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-26
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06864884 on ClinicalTrials.gov