A Phase 1 Study of ARC-001 in Participants Undergoing Third Molar Extraction
NCT ID: NCT06864884
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2025-02-26
2026-02-28
Brief Summary
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1. How much of the investigational product is absorbed in the blood?
2. Are there side effects?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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ARC-001
0.75 mL gel emulsion with active ingredient applied once to the surgical site.
ARC-001
Gel formulation containing investigational anesthetic.
Placebo
0.75 mL gel without active ingredient applied once to the surgical site.
Placebo gel
Gel that contains no active ingredients.
Interventions
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ARC-001
Gel formulation containing investigational anesthetic.
Placebo gel
Gel that contains no active ingredients.
Eligibility Criteria
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Inclusion Criteria
* In generally good health
* BMI 18 to 38kg/m²
* Scheduled to undergo wisdom teeth extraction
Exclusion Criteria
* Clinically significant abnormal lab values
* Blood donation in the last 60 days, or plasma donation in the last 7 days.
18 Years
55 Years
ALL
No
Sponsors
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Arcato Laboratories, Inc.
INDUSTRY
Responsible Party
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Locations
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CenExel JBR
Salt Lake City, Utah, United States
Countries
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Facility Contacts
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Other Identifiers
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ARC-001-101
Identifier Type: -
Identifier Source: org_study_id
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