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

ConditionsAcute Post Operative Pain Third Molar Extraction Surgery

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorArcato Laboratories, Inc.

About 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 does not accept healthy volunteers

Qualifiers

Able to provide informed consent

In generally good health

BMI 18 to 38kg/m²

Scheduled to undergo wisdom teeth extraction

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: ARC-001Experimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arcato Laboratories, Inc.

Lead sponsor

Source ClinicalTrials.gov

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