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

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

Completed

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Key information

Conditions

Healthy

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XAF5, concentration A

Drug

XAF5, concentration B

Drug

XAF5, concentration C

Drug

Placebo

Drug

Sponsors and collaborators

Lead sponsor

Topokine Therapeutics, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Nov 7, 2012
Registry last updated: Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed