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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02106260

Enrollment

Registered

2014-04-08

Start date

2014-03-31

Completion date

Unknown

Last updated

2014-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cutaneous Warts

Keywords

safety, pharmacokinetics (PK), pharmacodynamics (PD), CLS003

Brief 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.

Interventions

DRUGCLS003

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

* 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.

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026