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Recruiting NCT06864884

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

Early Phase I Interventional Acute Post Operative Pain Third Molar Extraction Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ARC-001, Placebo gel.
Who it may be relevant to
Registry conditions: Acute Post Operative Pain, Third Molar Extraction Surgery. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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?

Interventions

  • Drug ARC-001
    Gel formulation containing investigational anesthetic.
  • Drug Placebo gel
    Gel that contains no active ingredients.

Primary outcome measures

  • Safety and Tolerability [Time frame: 28 Days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • CenExel JBR — Salt Lake City

Identifiers

NCT: NCT06864884 · ARC-001-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗