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

May 21, 2014 updated by: Maruho Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zernikedreef 8, Netherlands
        • Centre for Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLS003
Drug: CLS003

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) of CLS003
Time Frame: 7 days
7 days
Number of participants with adverse events
Time Frame: 7 days
7 days
Peak Plasma Concentration (Cmax) of CLS003
Time Frame: 7 days
7 days
Time to reach Cmax (Tmax)
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maruho Co., Ltd.

Investigators

  • Principal Investigator: J. (Koos) Burggraaf, MD, PhD, Centre for Human Drug Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 3, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS003-CO-PR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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