First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts

A Phase I/IIa Open-label First-in-Human Study to Assess Safety and Pharmacokinetics and Explore Biomarker Effects of Topical Ionic Contra-viral Therapy (ICVT) Comprised of CLS003 in Subjects With Cutaneous Warts

This phase I/IIa study has an open-label, First-in-Human (FIH), single center design to assess the safety, pharmacokinetics (PK) and pharmacodynamics (PD) of multiple doses of topically applied CLS003 in healthy subjects with cutaneous warts.

Inclusion Criteria:

• Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive.
• Body mass index (BMI) between 18 and 30kg/m2, inclusive
• Fitzpatrick skin type I-II-III-IV
• At least 4 cutaneous warts on the hands, separated by at least 1cm of skin

Exclusion Criteria:

• For women, a positive pregnancy test and/or nursing at screening
• A positive test for drugs of abuse at screening
• History of alcohol or illicit drug abuse
• Positive test results for Hepatitis B, Hepatitis C or HIV
• Have used salicylic acid or any other over-the-counter- wart-removing product in the treatment area within 30 days prior to enrollment
• Have received cryotherapy in the treatment area within 60 days prior to enrollment
• Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) with 30 days prior to enrollment or during the course of the study.