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 digoxin and furosemide in subjects with cutaneous warts.
- Conditions
- cutaneous warts10014982
- Registration Number
- NL-OMON41213
- Lead Sponsor
- Cutanea Life Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 12
1. Healthy subjects (male, non-pregnant female), 18 to 65 years of age, inclusive. (Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, haematology, blood chemistry, and urinalysis.);
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive;
3. Fitzpatrick skin type I-II-III-IV;
4. At least 4 cutaneous warts on the hands, separated by at least 1 cm of skin;
1. Any clinically significant abnormality as determined by medical history taking and physical examinations obtained during the screening visit that in the opinion of the investigator would interfere with the study objectives or compromise subject safety;
2. For women: a positive pregnancy test and/or nursing at screening;
3. A positive test for drugs of abuse at screening;
4. Have used salicylic acid or any other over-the-counter wart-removing product in the treatment area within 30 days prior to enrolment;
5. Have received cryotherapy in the treatment area within 60 days prior to enrolment;
6. Have required systemic intake of immunosuppressive or immunomodulatory medication (including oral or parenteral corticosteroids) within 30 days prior to enrolment or during the course of the study. Routine use of inhaled or intranasal corticosteroids during the study is allowed;
7. Subjects currently using systemic digoxin or furosemide or any of the following prohibited medications (Note: exceptions will only be made if the rationale is discussed and clearly documented between the investigator and the sponsor):;Potential drug interactions with furosemide:
Aminoglycoside antibiotics
Ethacrynic acid
Salicylates
Cisplatin
Tubocurarine
Suyccinlycholine
Lithium
ACE inhibitors
Chloral hydrate
Phenytoin
Methotrexate
Cephalosporins
Cyclosporine;Potential drug interactions with digoxin:
Potassium-depleting diuretics
Quinidine
Verapamil
Amiodarone
Propafenone
Indomethacin
Intraconazole
Alprazolam
Spironolactone
Beta-adrenergic blocking agents
Calcium channel blockers;8. Have any current and / or recurrent pathologically relevant skin infections in the treatment area other than common warts (with the exception of herpes simplex virus labialis);
9. Have any current uncontrolled infection;
10. Atopic dermatitis or any other skin diseases involving chronic inflammation or reducing the skin barrier function;
11. Have a known sensitivity to any of the investigational product ingredients, including digoxin and furosemide.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Tolerability / safety endpoints<br /><br>Adverse events (AE) will be collected throughout the study, at every study<br /><br>visit. Laboratory safety testing, 12-Lead ECGs and vital signs will be<br /><br>performed and measured multiple times during the course the study according to<br /><br>the Visit and Assessment Schedule (protocol, table 1).<br /><br><br /><br>Pharmacokinetic endpoints<br /><br>Samples for pharmacokinetic determination of plasma digoxin and furosemide<br /><br>concentrations will be collected according to the Visit and Assessment Schedule<br /><br>(protocol, table 1). Samples will be tested by validated HPLC/MS/MS with a<br /><br>lower limit of quantification (LLOQ) of 0.05 ng/mL.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Efficacy / pharmacodynamic endpoints<br /><br>Pharmacodynamic effects of CLS003 will be assessed at the time points indicated<br /><br>in the Visit and Assessment Schedule (protocol, table 1) by<br /><br>• Morphological wart assessment on-site;<br /><br>• Wart size and morphology assessment by standardized clinical photography;<br /><br>• HPV viral load assessment of target lesions by quantitative PCR (exploratory<br /><br>biomarker).</p><br>