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

Early Phase 1RecruitingNCT06864884

Arcato Laboratories, Inc.30 enrolled

Overview

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?

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Acute Post Operative Pain Third Molar Extraction Surgery

Interventions

ARC-001DRUG

Gel formulation containing investigational anesthetic.

Placebo gelDRUG

Gel that contains no active ingredients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

CenExel JBR

Salt Lake City, Utah, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 28 Days

Data from ClinicalTrials.gov

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