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

NCT ID: NCT06864884

Last Updated: 2025-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-26

Study Completion Date

2026-02-28

Brief Summary

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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?

Detailed Description

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Conditions

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Acute Post Operative Pain Third Molar Extraction Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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ARC-001

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

Group Type EXPERIMENTAL

ARC-001

Intervention Type DRUG

Gel formulation containing investigational anesthetic.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo gel

Intervention Type DRUG

Gel that contains no active ingredients.

Interventions

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ARC-001

Gel formulation containing investigational anesthetic.

Intervention Type DRUG

Placebo gel

Gel that contains no active ingredients.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arcato Laboratories, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CenExel JBR

Salt Lake City, Utah, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Recruiter

Role: primary

801-261-2000

Other Identifiers

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ARC-001-101

Identifier Type: -

Identifier Source: org_study_id

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