Cutaneous WartsPhase 1/2NCT02106260
First-in-Human Study of CLS003 ICVT in Subjects With Cutaneous Warts
A Phase 1/2 study testing CLS003 in people with Cutaneous Warts, run by Maruho Co., Ltd. at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Warts
- What is being tested?
- CLS003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2014to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cutaneous Warts
- Being tested
- CLS003
- Keywords
- safety, pharmacokinetics (PK), pharmacodynamics (PD), CLS003
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLS003Drug
| Study group | Role | What they receive |
|---|---|---|
| CLS003 | Experimental | Not described Receives: Drug: CLS003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of CLS003
Measured: 7 days
Number of participants with adverse events
Measured: 7 days
Peak Plasma Concentration (Cmax) of CLS003
Measured: 7 days
Time to reach Cmax (Tmax)
Measured: 7 days
Secondary outcomes (1)
Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous WartsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maruho Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. (Koos) Burggraaf, MD, PhD, Principal investigator, Centre for Human Drug Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106260
- Sponsor's protocol ID
- CLS003-CO-PR-001
- Status last verified
- May 2014
- First submitted
- 2 Apr 2014
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02106260
- Acronym / sponsor ID
- CLS003-CO-PR-001
- Conditions
- Cutaneous Warts
- Keywords
- safety, pharmacokinetics (PK), pharmacodynamics (PD), CLS003
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maruho Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- First posted
- 8 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CLS003 | Experimental | Drug: CLS003 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CLS003 | Drug | CLS003 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of CLS003
Time frame: 7 days
Number of participants with adverse events
Time frame: 7 days
Peak Plasma Concentration (Cmax) of CLS003
Time frame: 7 days
Time to reach Cmax (Tmax)
Time frame: 7 days
1 secondary outcome
Pharmacodynamic effects of topically applied CLS003 on wart morphology and HPV viral load
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
Related trials for Cutaneous Warts
Enrolling by invitationEarly Phase 1
Role of Intralesional Combined Injection of Furosemide and Digoxin in Cutaneous Warts at Tertiary Care Hospital in Karachi.
Cutaneous Warts
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. (Koos) Burggraaf, MD, PhD principal investigator
Centre for Human Drug Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CLS003 in people with Cutaneous Warts, run by Maruho Co., Ltd. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of CLS003 (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.