This Phase 1 study is intended to explore the safety, tolerability, pharmacodynamics and efficacy of topical CyPep-1 as a potential treatment for HPV-associated conditions. Since this is a first-on-human study of a topical formulation, the first subjects will be monitored more frequently in order to establish the safety profile. Because clinical outcomes (i.e. reduction/clearance of the lesion) often require lengthy treatment / observation periods, the study design will primarily utilize clinical measurements of wart dimensions, along with HPV viral load as a biomarker of anti-viral effect.
This study has a phase 1, randomized, vehicle-controlled, double-blind, single center design to explore the safety, tolerability and pharmacodynamics (PD) of topically applied CyPep-1 in otherwise healthy patients with cutaneous warts. The study will entail two parts. Part 1 will follow a target area of 5x5 cm healthy skin to study tolerability and safety of the formulation. During this study part also a maximum of 3 common warts, preferably at the dorsal or palmar side of the hand / finger(s), will be treated. Several assessments will be done to determine pharmacodynamics and to explore possible efficacy after a treatment period of 1 week. Part 2 will evaluate the pharmacodynamics and efficacy of CyPep-1 after a treatment period of 4 weeks. Study part 2 will commence after an interim analysis, e.g. a blind data review, of study part 1 has been conducted.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Eligible subjects will be randomized to one of the two treatment groups in a ratio of 1:1 (active:placebo). The treatment groups are: * CyPep-1 topical formulation 1% (w/w) * Vehicle topical formulation (placebo) The minimum set of studied warts is 1 treated common wart per subject. The subjects will be randomly assigned to treatment. During the treatment period topical formulation will be applied daily on to a maximum of 3 warts. One selected wart will serve as target wart, i.e. the primary wart, for detailed analysis. Selection of warts will be based on the feasibility to conduct treatment application and pharmacodynamics (including biopsy sampling) on the region of interest.
Centre for Human Drug Research
Leiden, South Holland, Netherlands
Changes in heart rate
Part 1: Heart rate (number of pulses/min) will be measured during the time points described below.
Time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Changes in blood pressure (systolic and diastolic)
Blood pressure (mmHg) will be measured during the time points described below.
Time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Changes in body temperature
Body temperature (degrees Celsius) will be measured during the time points described below.
Time frame: Part 1: Baseline, 0.5h, 2h, 4h, 8h, 24h, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 14, Day 21. Part 2: All study visits.
Recording of (S)AEs
AEs and AEs will be recorded during all visits.
Time frame: At all study visits.
Changes in wart size
Wart size (in mm) will be measured during the time points described below.
Time frame: Part 1: Baseline, 24h,Day 3, Day 5, Day 7, Day, 14 and Day 21, Part 2: all study visits
HPV viral load
Part 1: Swabs will be obtained every 48h during treatment period and at the FU visits. Part 2: Swabs will be obtained at all study visits.
Time frame: 24-48h during Part 1, 1-6 weeks during Part 1 and Part 2
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