NCT01723241CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Topokine Therapeutics, Inc.
- Enrollment
- 32
Study Overview
Brief Summary
This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when applied to the skin of healthy volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
XAF5
Experimental
Intervention: XAF5, concentration A (Drug)
XAF5
Experimental
Intervention: XAF5, concentration B (Drug)
XAF5
Experimental
Intervention: XAF5, concentration C (Drug)
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
Investigators
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