Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers

A Randomized, Placebo-controlled, Double-blind, Multiple-ascending-dose Study to Assess the Safety and Tolerability of XAF5 Gel Applied to the Skin of Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01723241

Enrollment

Registered

2012-11-07

Start date

2012-11-30

Completion date

2013-04-30

Last updated

2016-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

volunteers

Brief summary

This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.

Interventions

DRUGXAF5, concentration A

DRUGXAF5, concentration B

DRUGXAF5, concentration C

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 60 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy volunteers * Must understand and provide informed consent * Skin upon which a reaction would be visible * Body weight \>= 70 kg

Exclusion criteria

* Any active skin disease * History of skin hypersensitivity * Clinically significant abnormality on physical exam, ECG, or laboratory tests * Positive test for HIV, Hepatitis B, or Hepatitis C

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026