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CompletedNCT02106260Updated May 23, 2014

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

A Phase 1/2 interventional study of CLS003 in Cutaneous Warts, sponsored by Maruho Co., Ltd.. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-05-23.

Sponsored by Maruho Co., Ltd. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Cutaneous Warts

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Keywords

  • safety
  • pharmacokinetics (PK)
  • pharmacodynamics (PD)
  • CLS003
03

In context

Warts

180 studies on the registry are indexed under Warts; 28 are open to participants now.

This study's enrollment of 12 is below the median of 70 across 159 interventional studies indexed under Warts.

Browse Warts studies →

Lead sponsor

Maruho Co., Ltd. is the lead sponsor of 24 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    CLS003

    Drug: CLS003

Interventions

  • DrugCLS003
06

What researchers measure

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

07

Study locations

1 site
  • Centre for Human Drug Research
    Zernikedreef 8, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02106260
Lead sponsor
Maruho Co., Ltd.
Responsible party
Sponsor
First posted
Apr 8, 2014
Start date
Mar 2014
Primary completion
Apr 2014
Last update
May 23, 2014

Study contacts

J. (Koos) Burggraaf, MD, PhD
principal investigator · Centre for Human Drug Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.

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