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Recruiting

NCT Number: NCT06864884

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

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?

Recruiting

Interested in participating?

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Key information

Conditions

Acute Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Third Molar Extraction Surgery

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

CenExel JBR

Salt Lake City, Utah, 84107, United States

Location status: Recruiting

Location contact

Recruiter

CONTACT

[email protected]

801-261-2000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ARC-001

Drug

Gel formulation containing investigational anesthetic.

Placebo Gel

Drug

Gel that contains no active ingredients.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Arcato Laboratories, Inc.

Industry

Registry information

Official study title

A Phase 1 Randomized, Placebo-Controlled, Blinded Study Evaluating the Safety, Tolerability, and Pharmacokinetics of ARC-001 in Participants Undergoing Third Molar Extraction

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2025
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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