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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431610 on ClinicalTrials.gov