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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cutaneous Warts

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLS003

Group Type EXPERIMENTAL

CLS003

Intervention Type DRUG

Interventions

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CLS003

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes