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

Phase 1

Completed

• Conditions: Cutaneous Warts
• Interventions: Drug: CLS003

• Registration Number: NCT02106260
• Lead Sponsor: Maruho Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Primary Completion: 2014-04
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-21
• Last Update Posted: 2014-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CLS003	CLS003	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Centre for Human Drug Research; 🇳🇱 Zernikedreef 8, Netherlands