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

NCT ID: NCT01723241

Last Updated: 2016-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2013-04-30

Brief Summary

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

XAF5

Group Type: EXPERIMENTAL

XAF5, concentration A

Intervention Type: DRUG

XAF5, concentration B

Intervention Type: DRUG

XAF5, concentration C

Intervention Type: DRUG

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Interventions

XAF5, concentration A

Intervention Type: DRUG

XAF5, concentration B

Intervention Type: DRUG

XAF5, concentration C

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Topokine Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael S. Singer, MD, PhD

Role: STUDY_DIRECTOR

Topokine Therapeutics

Other Identifiers

XAF5 A1

Identifier Type: -

Identifier Source: org_study_id