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NCT03431610 · ClinicalTrials.gov registry record · Phase 1

A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis

A Phase 1 study, sponsored by Novan.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target

NCT03431610: Completed Phase 1 study, sponsored by Novan.

NCT03431610 is a Phase 1 study that has completed, run by Novan. The registered enrollment target is 48 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03431610, a Phase 1 study, has completed, sponsored by Novan.

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target

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.

Primary Outcome

Peak plasma concentrations of hMAP3 after topical application of SB414

Interventions

  • DRUG Vehicle
  • DRUG SB414 2%
  • DRUG SB414 6%

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2017-11-13
Est. Completion 2018-05-11
Phase Phase 1
Novan

18 total trials

What the finished NCT03431610 record still lists

NCT03431610 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).

The record links to 0 conditions, and to 3 interventions - of which Vehicle is the first listed.

NCT03431610 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03431610 about?

NCT03431610 is a clinical study titled "A Phase 1b Study Assessing the PK, PD, Safety & Tolerability of SB414 in Atopic Dermatitis". This is a Phase 1b, 2-week study assessing the pharmacokinetics, pharmacodynamics, safety and tolerability of SB414 in subjects with mild to moderate AD.

What is the current status of trial NCT03431610?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2017-11-13. Estimated completion is 2018-05-11.

What interventions are being tested in trial NCT03431610?

The interventions under investigation include: Vehicle (DRUG), SB414 2% (DRUG), SB414 6% (DRUG).

Who is sponsoring clinical trial NCT03431610?

This trial is sponsored by Novan, which has 18 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03431610's enrollment target sits among peer trials

48 1025th of 2000 higher than 948 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03431610, the US trial registry maintained by the National Library of Medicine. NCT03431610 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.