Trials / Withdrawn
WithdrawnNCT03939364
This Study is to Evaluate the Safety and Pharmacokinetics of SBS-101 in Patients With Oral Premalignant Lesions
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)
- Status
- Withdrawn
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Skyline Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SBS-101 | Isotretinoin Oral-Adhesive Film |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2022-01-01
- Primary completion
- 2023-04-01
- Completion
- 2023-05-01
- First posted
- 2019-05-06
- Last updated
- 2021-10-19
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03939364. Inclusion in this directory is not an endorsement.