Back to results

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

Primary Purpose

Cutaneous Warts

Status

Completed

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

CLS003

About this trial

This is an interventional treatment trial for Cutaneous Warts focused on measuring safety, pharmacokinetics (PK), pharmacodynamics (PD), CLS003

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Centre for Human Drug Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CLS003

Arm Description

Outcomes

Primary Outcome Measures

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

Number of participants with adverse events

Peak Plasma Concentration (Cmax) of CLS003

Time to reach Cmax (Tmax)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02106260

First Posted

April 2, 2014

Last Updated

May 21, 2014

Sponsor

Maruho Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02106260

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Maruho Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cutaneous Warts

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CLS003

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

CLS003

Primary Outcome Measure Information:

Title

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

Time Frame

7 days

Title

Number of participants with adverse events

Time Frame

7 days

Title

Peak Plasma Concentration (Cmax) of CLS003

Time Frame

7 days

Title

Time to reach Cmax (Tmax)

Time Frame

7 days

Secondary Outcome Measure Information:

Title

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

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J. (Koos) Burggraaf, MD, PhD

Organizational Affiliation

Centre for Human Drug Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre for Human Drug Research

City

Zernikedreef 8

Country

Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs