This study is an open-label, placebo-controlled, first-in-human clinical trial in healthy adults, designed to assess the safety, tolerability, and PK characteristics of various doses of WS-0101 following different light power density exposures. Each subject will receive the drug on the left upper arm and placebo on the right upper arm, followed by photodynamic therapy (PDT). Based on non-clinical results and considering systemic safety, the drug concentrations tested will be 5%, 10%, and 20%, and light power densities will be 40 and 80 mW/cm². The PDT equipment, provided by the sponsor, is the WS-L-01 device, with data on any related device defects collected for safety evaluation.
Overall Study Design: * Open-label, placebo-controlled, single-dose, dose-escalation study. * The study includes 5 groups with varying drug concentrations and light power densities. Group Drug Concentration Application Area Light Duration Light Power Density Sample Size 1-1 5% 3 cm diameter 1000 s 40 mW/cm² 3 1-2 5% 3 cm diameter 1000 s 80 mW/cm² 6 2-1 10% 3 cm diameter 1000 s 40 mW/cm² 6 2-2 10% 3 cm diameter 1000 s 80 mW/cm² 6 3 20% 3 cm diameter 1000 s 80 mW/cm² 6 Placebo Control: Self-controlled. Total Number of Subjects: 27 Dose Escalation Principles 1. The study will start with the lowest dose group, following the sequence shown in the table. If only one exploratory condition is added between groups, multiple dose groups may escalate simultaneously (e.g., Group 1-1 to Groups 1-2 and 2-1). After completing the observation of Group 2-1, the dose can escalate to Group 2-2, and after observing Group 2-2, it can proceed to Group 3. 2. Each dose group will be observed for at least 7 days following the first subject's dosing before escalating to the next group. The Safety Review Committee (SRC) will evaluate safety and tolerability before allowing progression to the next group. 3. The decision to move to the next dose level will be made by the SRC through a consensus decision-making process, which may involve meetings, teleconferences, or email responses. Specific processes will be detailed in a separate SRC charter. 4. Dose adjustments, either increases or decreases, will be based on the safety and tolerability results of the current group. Possible adjustments to the planned dose escalation include: * Lower than the starting dose. * Intermediate doses between the current and preceding dose. * Intermediate doses between the current and next planned dose. * Repeat the current dose. * Terminate further dose escalation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
27
Use light power density and light duration 40 mW/cm²\*1000s treatment
Use light power density and light duration 80 mW/cm²\*1000s treatment
Peking University First Hospital
Beijing, Beijing Municipality, China
To evaluate the safety and tolerability of different topical doses of WS-0101, followed by varying light power densities, in healthy adult subjects
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0, Change From Baseline in Pain Scores on the Numerical Rating Scale (NRS) at 2 Weeks
Time frame: Visit 11 (Day14)
Assess PK characteristics of single-dose topical WS-0101 in healthy adults and evaluate the safety of the laser therapy device based on defect incidence
Non-compartmental analysis using WinNonlin will be used to estimate PK parameters such as Cmax, AUC0-t, AUC0-∞, and Tmax. Descriptive statistics for Cmax, AUC0-t, Tmax, and other parameters will be provided and listed. Boxplots will be drawn for key PK parameters such as Cmax, AUC0-t, and AUC0-∞ by dose group. If plasma exposure is too low and there are insufficient quantifiable concentrations to calculate relevant PK parameters, only concentration data and/or partial parameters will be listed.
Time frame: Visit 6 (Day 1)
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