Acute Post Operative PainEarly Phase 1NCT06864884
A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
A Early Phase 1 study testing ARC-001 in people with Acute Post Operative Pain and Third Molar Extraction Surgery, run by Arcato Laboratories, Inc. at 1 site in United States.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Acute Post Operative Pain, Third Molar Extraction Surgery
- What is being tested?
- ARC-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to Feb 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to provide informed consent
- In generally good health
- BMI 18 to 38kg/m²
- Scheduled to undergo wisdom teeth extraction
Who cannot join
- Serious medical condition
- Clinically significant abnormal lab values
- Blood donation in the last 60 days, or plasma donation in the last 7 days.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
CenExel JBR
Salt Lake City, Utah, 84107
Recruiter, 801-261-2000, participate@jbrutah.com
About this study
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
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:
- How much of the investigational product is absorbed in the blood?
- Are there side effects?
- Being tested
- ARC-001, Placebo gel
- Keywords
- wisdom teeth surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARC-001Drug
Gel formulation containing investigational anesthetic.
Placebo gelDrug
Gel that contains no active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| ARC-001 | Experimental | 0.75 mL gel emulsion with active ingredient applied once to the surgical site. Receives: Drug: ARC-001 |
| Placebo | Placebo comparator | 0.75 mL gel without active ingredient applied once to the surgical site. Receives: Drug: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start26 Feb 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arcato Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06864884
- Sponsor's protocol ID
- ARC-001-101
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06864884
- Acronym / sponsor ID
- ARC-001-101
- Keywords
- wisdom teeth surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Arcato Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 7 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How much of the investigational product is absorbed in the blood?
- Are there side effects?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARC-001 | Experimental | Drug: ARC-0010.75 mL gel emulsion with active ingredient applied once to the surgical site. |
| Placebo | Placebo comparator | Drug: Placebo gel0.75 mL gel without active ingredient applied once to the surgical site. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to provide informed consent
- In generally good health
- BMI 18 to 38kg/m²
- Scheduled to undergo wisdom teeth extraction
Key exclusion criteria (3 listed)
- Serious medical condition
- Clinically significant abnormal lab values
- Blood donation in the last 60 days, or plasma donation in the last 7 days.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARC-001Gel formulation containing investigational anesthetic. | Drug | ARC-001 |
| Placebo gelGel that contains no active ingredients. | Drug | Placebo |
Primary outcome
Safety and Tolerability
Time frame: 28 Days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ARC-001 in people with Acute Post Operative Pain and Third Molar Extraction Surgery, run by Arcato Laboratories, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.