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

Arcato Laboratories, Inc.

Status and phase: Enrolling; Early Phase 1

Conditions: Acute Post Operative Pain; Third Molar Extraction Surgery

Treatments: Drug: ARC-001; Drug: Placebo gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT06864884

ARC-001-101

Details and patient eligibility

About

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?

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

ARC-001

Experimental group

Description:

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

Treatment:

Drug: ARC-001

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo gel