First-in-Human Study of CLS003 ICVT in Subjects With Cuta... | NCT02106260

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

NCT02106260

Sponsor

Maruho Co., Ltd.

Status

Completed

Last Update Posted

May 23, 2014Estimated

Enrollment

12Actual

Phase

Phase 1Phase 2

Conditions

Cutaneous Warts

Interventions

CLS003

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2014

Primary Completion Date

Apr 2014Actual

Completion Date

Not provided

First Submitted Date

Apr 2, 2014

First Submission Date that Met QC Criteria

Apr 3, 2014

First Posted Date

Apr 8, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2014

Last Update Posted Date

May 23, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
CLS003	Experimental		Drug: CLS003

Name	Type	Description	Arm Group Labels	Other Names
CLS003	Drug		CLS003

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J. (Koos) Burggraaf, MD, PhD	Centre for Human Drug Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Human Drug Research		Zernikedreef 8			Netherlands