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Completed

NCT Number: NCT02106260

First-in-Human Study of CLS003 ICVT 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.

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Key information

Conditions

Cutaneous Warts

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Centre for Human Drug Research

Zernikedreef 8, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CLS003

Drug

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) of CLS003

    Time frame: 7 days

  2. Number of participants with adverse events

    Time frame: 7 days

  3. Peak Plasma Concentration (Cmax) of CLS003

    Time frame: 7 days

  4. Time to reach Cmax (Tmax)

    Time frame: 7 days

Secondary outcomes

  1. Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Maruho Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
First posted
Apr 8, 2014
Registry last updated
May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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