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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: XAF5, concentration A; Drug: XAF5, concentration B; Drug: XAF5, concentration C

• Registration Number: NCT01723241
• Lead Sponsor: Topokine Therapeutics, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-05
• Study First Submitted QC: 2012-11-06
• Study First Posted: 2012-11-07
• Status Verified: 2013-04
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Last Update Submitted: 2016-01-09
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XAF5	XAF5, concentration C	-
Placebo	Placebo	-
XAF5	XAF5, concentration A	-
XAF5	XAF5, concentration B	-