Spots Global Cancer Trial Database for This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions
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Trial Identification
Brief Title: This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions
Official Title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of SBS-101 After Intraoral Application in Patients With Oral Premalignant Lesions (OPL)
Study ID: NCT03939364
Conditions
Study Description
Brief Summary: This study will be the first study investigating the safety, pharmacokinetics (PK), and efficacy of SBS-101 on oral pre-malignant lesions. As such, no clinical data has yet been generated using SBS-101 oral adhesive film.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham (UAB) - The Kirklin Clinic (TKC), Birmingham, Alabama, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Carolinas Center for Oral Health, Charlotte, North Carolina, United States
PennState Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States
University of Texas Southwestern Medical Center - Oral & Maxillofacial Surgery Clinic, Dallas, Texas, United States
Contact Details
Name: Joy Schleyer
Affiliation: Skyline Biosciences
Role: STUDY_DIRECTOR
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