ARC-001 for Postoperative Pain

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Arcato Laboratories, Inc.

Disqualifiers: Serious medical condition, abnormal labs, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

30 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the purpose of this trial?

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?

Eligibility Criteria

This trial is for individuals who are undergoing wisdom tooth extraction and want to manage postoperative pain. Participants should be healthy adults without any known allergies or conditions that could interfere with the study.

Inclusion Criteria

I am scheduled for wisdom teeth removal.

I am in good overall health.

Able to provide informed consent

Exclusion Criteria

I have not donated blood in the last 60 days or plasma in the last 7 days.

I have a serious health condition.

Presence of clinically significant abnormal lab values

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single application of the investigational product gel or placebo to the surgical site after wisdom tooth extraction

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of oral treatment-emergent adverse events and serious adverse events

4 weeks

Multiple visits (in-person) for oral exams

Treatment Details

Interventions

• ARC-001

Trial Overview The study is testing ARC-001, a new gel product, against a placebo to see if it's safe and how much gets into the blood after being applied in the mouth following wisdom tooth surgery.

Participant Groups

Group I: ARC-001 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Arcato Laboratories, Inc.

Lead Sponsor

Trials

1

Recruited

30+