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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new gel called ARC-001 to determine its safety and effectiveness in managing pain after wisdom tooth removal. The goal is to measure how much of the gel enters the bloodstream and identify any side effects. Participants will receive either the gel with the active ingredient or a placebo gel applied to their surgical site. Individuals in generally good health who plan to have their wisdom teeth removed may qualify for this study. As an Early Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

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.

Is there any evidence suggesting that ARC-001 is likely to be safe for humans?

A previous study tested ARC-001 to assess its safety for individuals after wisdom teeth removal. As an early-stage study, detailed safety information is limited. Such trials aim to determine if a treatment is safe for humans, often starting with small doses to monitor side effects. Progression to later stages typically indicates initial safety findings. Currently, there is no clear data on how well ARC-001 is tolerated. Participants in this trial will contribute to understanding its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike typical treatments for postoperative pain, which often involve oral painkillers like opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), ARC-001 is a gel emulsion applied directly to the surgical site. This localized delivery method aims to target pain more precisely, potentially reducing the need for systemic medications and minimizing related side effects. Additionally, ARC-001 utilizes a novel active ingredient designed to provide effective pain relief with just a single application, offering a promising alternative to current multi-dose pain management strategies. Researchers are excited about the possibility of more efficient pain control and fewer side effects, which could significantly improve patient recovery experiences.

What evidence suggests that ARC-001 might be an effective treatment for postoperative pain?

Research shows that ARC-001, which participants in this trial may receive, might help manage post-surgical pain. Previous studies have found that similar treatments can reduce pain and the need for strong painkillers after surgery. For example, one study showed that certain methods effectively lowered immediate pain and opioid use, meaning patients felt less pain and needed fewer strong painkillers. Although data on ARC-001 remains limited, it is based on these successful methods, suggesting it might help reduce pain after wisdom teeth removal. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. withpower.com withpower.com/trial/early-phase-1-pain-postoperative-1-2025-6a1b1

ARC-001 for Postoperative Pain This trial is for individuals who are undergoing wisdom tooth extraction and want to manage postoperative pain. Participants should be healthy adults without ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10654400/

Development and prospective validation of postoperative pain ... AUCs ranged from 0.67 to 0.76 on postoperative days 0 through 4 for predictions of moderate pain (Fig.

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-025-08822-w

ARC (Australian Rotator Cuff) trial: study protocol for a ... The primary outcome will be shoulder pain and function measured using the Western Ontario Rotator Cuff Index at 6 months post-surgery.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0007091225003447

Association of peripheral nerve blocks with increased ... Although single injection peripheral nerve blocks were effective in reducing immediate postoperative pain and opioid consumption, they were associated with ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28632527/

Assessment of Postoperative Analgesic Drug Efficacy Results: Sixty-one patients were included in the final data analysis. Discrete pain intensity ratings differed significantly between the treatment groups at ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0144016

Postoperative Pain, Acute (DBCOND0144016) - DrugBank This is a Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After Surgical Removal of Impacted Third Molars. LTG-001; Suzetrigine. treatment, 2 ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/P110013S005b.pdf

summary of safety and effectiveness data (ssed) • Pain (abdominal, arthralgia, injection site). • Rash. Potential adverse ... The ARC-defined MI rates are considerably higher than the protocol-defined.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9388431/

Systematic review and meta-analysis of postoperative pain ... Our study suggests that LHP is more tolerable than CoH, providing patients with superior postoperative quality of life at equivalent moderate-term efficacy.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03541655?spons=COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Arthritis%20Innovation%20Corporation%22)&viewType=Table&rank=3

Safety and Activity of F14 for Management of Pain ... Post-operative pain will be assessed using visual analog scores (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaires ...