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

Cutaneous Warts Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02106260
• Other study ID #: CLS003-CO-PR-001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 2, 2014
• Last updated: May 21, 2014
• Start date: March 2014

Study information

• Verified date: May 2014
• Source: Cutanea Life Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cutaneous Warts
• Warts

Intervention

Drug:
• CLS003

Locations

Country	Name	City	State
Netherlands	Centre for Human Drug Research	Zernikedreef 8

Sponsors (1)

Lead Sponsor	Collaborator
Cutanea Life Sciences, Inc.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the plasma concentration versus time curve (AUC) of CLS003		7 days	No
Primary	Number of participants with adverse events		7 days	Yes
Primary	Peak Plasma Concentration (Cmax) of CLS003		7 days	No
Primary	Time to reach Cmax (Tmax)		7 days	No
Secondary	Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load		7 days	No