NCT06857799

A Study on the Safety, Tolerability and Pharmacokinetics of WS-0101 Tablets in Chinese Healthy Subjects

An Open-Label, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Topical WS-0101 in Healthy Adult Subjects: a First-in-Human Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Peking University First Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
PROCEDURE	Light Power Density and Light Duration 40 mW/cm²*1000s	Use light power density and light duration 40 mW/cm²\*1000s treatment
PROCEDURE	Light Power Density and Light Duration 80 mW/cm²*1000s	Use light power density and light duration 80 mW/cm²\*1000s treatment

Timeline

• Start date: 2024-05-13
• Primary completion: 2024-06-28
• Completion: 2024-09-23
• First posted: 2025-03-04
• Last updated: 2025-03-04

Locations

1 site across 1 country: China