A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis
NCT03431610 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2018-09-07
Summary
This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.
Conditions
Interventions
- DRUG
-
SB414 2%
Twice daily
- DRUG
-
SB414 6%
Twice daily
- DRUG
-
Vehicle
Placebo comparator
Sponsors & Collaborators
-
Novella Clinical
collaborator OTHER -
Novan, Inc.
lead INDUSTRY
Principal Investigators
-
Tomoko Maeda-Chubachi · Novan, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-11-13
- Primary Completion
- 2018-05-11
- Completion
- 2018-05-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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