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

NCT06864884 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: ARC-001-101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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:

1. 1.How much of the investigational product is absorbed in the blood?
2. 2.Are there side effects?

Conditions

Acute Post Operative Pain; Third Molar Extraction Surgery

Keywords

wisdom teeth surgery

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  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.

  28 Days

Study Arms (2)

ARC-001

EXPERIMENTAL

0.75 mL gel emulsion with active ingredient applied once to the surgical site.

Drug: ARC-001

Placebo

PLACEBO COMPARATOR

0.75 mL gel without active ingredient applied once to the surgical site.

Drug: Placebo gel

Interventions

ARC-001 DRUG

Gel formulation containing investigational anesthetic.

ARC-001

Placebo gel DRUG

Gel that contains no active ingredients.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide informed consent
• In generally good health
• BMI 18 to 38kg/m²
• Scheduled to undergo wisdom teeth extraction

You may not qualify if:

• Serious medical condition
• Clinically significant abnormal lab values
• Blood donation in the last 60 days, or plasma donation in the last 7 days.

Sponsors & Collaborators

• Arcato Laboratories, Inc.: lead

Study Sites (1)

CenExel JBR

Salt Lake City, Utah, 84107, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 7, 2025
• Study Start: February 26, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)