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

Maruho

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cutaneous Warts

Treatments

Drug: CLS003

Study type

Interventional

Funder types

Industry

Identifiers

NCT02106260

CLS003-CO-PR-001

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.