NCT02106260

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
Last Updated

May 23, 2014

Status Verified

May 1, 2014

Enrollment Period

1 month

First QC Date

April 2, 2014

Last Update Submit

May 21, 2014

Conditions

Cutaneous Warts

Keywords

safetypharmacokinetics (PK)pharmacodynamics (PD)CLS003

Outcome Measures

Primary Outcomes (4)

  • 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 (1)

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

    7 days

Study Arms (1)

CLS003

EXPERIMENTAL
Drug: CLS003

Interventions

CLS003DRUG
CLS003

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Human Drug Research

Zernikedreef 8, Netherlands

Location

Study Officials

  • J. (Koos) Burggraaf, MD, PhD

    Centre for Human Drug Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 8, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2014

Last Updated

May 23, 2014

Record last verified: 2014-05

Locations

NL(1)