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

NCT06857799 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Healthy Adult Subjects

Interventions

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

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-13
Primary Completion
2024-06-28
Completion
2024-09-23

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06857799 on ClinicalTrials.gov