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
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