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

NCT06857799 | Completed Phase 1

• 1 other identifier: HS_WS-0101_101
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

  Visit 11 (Day14)

Secondary Outcomes (1)

• 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

  Visit 6 (Day 1)

Study Arms (3)

5% WS-0101/Placebo

ACTIVE COMPARATOR

Treat with 5% WS-0101 medication or placebo.

Procedure: Light Power Density and Light Duration 40 mW/cm²*1000s; Procedure: Light Power Density and Light Duration 80 mW/cm²*1000s

10% WS-0101/Placebo

ACTIVE COMPARATOR

Treat with 10% WS-0101 medication or placebo.

Procedure: Light Power Density and Light Duration 40 mW/cm²*1000s; Procedure: Light Power Density and Light Duration 80 mW/cm²*1000s

20% WS-0101/Placebo

ACTIVE COMPARATOR

Treat with 20% WS-0101 medication or placebo.

Procedure: Light Power Density and Light Duration 80 mW/cm²*1000s

Interventions

Light Power Density and Light Duration 40 mW/cm²*1000s PROCEDURE

Use light power density and light duration 40 mW/cm²\*1000s treatment

10% WS-0101/Placebo; 5% WS-0101/Placebo

Light Power Density and Light Duration 80 mW/cm²*1000s PROCEDURE

Use light power density and light duration 80 mW/cm²\*1000s treatment

10% WS-0101/Placebo; 20% WS-0101/Placebo; 5% WS-0101/Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects must meet the following criteria to be included in this study:
• Voluntarily participate in the study and provide a signed and dated informed consent form (ICF).
• Be a male or female adult between 18 and 55 years of age (inclusive).
• Male subjects must weigh at least 50 kg, and female subjects must weigh at least 45 kg, with a body mass index (BMI) between 18.5 and 28 kg/m² (inclusive).
• For female subjects:
• No reproductive potential, including at least 6 weeks post-surgical sterilization (documented tubal ligation, hysterectomy, or bilateral oophorectomy) or ≥12 months of postmenopausal status (with follicle-stimulating hormone (FSH) levels ≥40 IU/L).
• For women of childbearing potential, they must be non-pregnant, non-lactating, and must agree to use non-drug contraceptive methods for 30 days before administration, throughout the study, and for 3 months after dosing. Their human chorionic gonadotropin (hCG) test must be negative at screening and on Day -1, and they must not donate eggs during this period.
• For male subjects with female partners of childbearing potential, they must agree to use non-drug contraceptive methods for 14 days before administration, throughout the study, and for 3 months after dosing. Male subjects must not donate sperm during this period.
• Willingness to comply with the study protocol, including visits, study treatment, laboratory tests, and other study-related procedures and requirements.

You may not qualify if:

• Subjects meeting any of the following criteria will be excluded from the study:
• Known allergy to the study drug or its excipients, or allergy to blue light sources, or a history of severe allergies (including any food or drug allergies).
• A history of photosensitivity disorders, such as polymorphic light eruption, solar urticaria, chronic actinic dermatitis, porphyria, or any suspected photosensitivity based on the investigator's judgment.
• A history of recurrent skin infections, psychiatric disorders, a family history of psychiatric disorders, or chronic or serious conditions involving the central nervous system, cardiovascular system, liver, kidneys, lungs, digestive tract, metabolism, blood, or skeletal systems that could affect study participation or pose unacceptable risks.
• Sensitivity, infection, inflammation, redness, rash, sunburn, blistering, injury, pigmentation changes, or the presence of tattoos, birthmarks, or scars at the application site.
• Exposure of the upper arms to sunlight or artificial tanning within 48 hours prior to dosing.
• Keloid formation or scarring tendencies.
• Clinically significant abnormalities in vital signs, physical examination, or laboratory tests.
• Clinically significant abnormalities on a 12-lead electrocardiogram (ECG).
• A creatinine clearance rate (Ccr) of less than 90 mL/min, calculated using the Cockcroft-Gault formula: Ccr=((140-Age)\*Weight(Kg)\*(0.85 for women))/(72\*Serum creatinine (mg/dL))
• Alternatively: Ccr=((140-Age)\*Weight(Kg)\*(0.85 for women))/(0.81\*Serum creatinine (μmol/dL))
• Positive for human immunodeficiency virus antibodies (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCV-Ab), or syphilis antibodies (TP-Ab).
• Use of any prescription, over-the-counter medication, herbal medicine, or dietary supplements within 14 days before dosing, or use of photosensitizing or phototoxic drugs (e.g., quinolones, glibenclamide, sulfonamides, tetracyclines, chloramphenicol, phenothiazines) within 3 months before dosing.
• Known or suspected history of substance abuse (e.g., morphine, methamphetamine, ketamine, MDMA, THC, cocaine), or a positive drug screen.
• Excessive alcohol consumption (more than 21 units per week; one unit equals 14 g alcohol, e.g., 360 mL of 5% beer, 45 mL of 40% spirits, or 120 mL of 12% wine) within 1 year prior to screening, or a positive alcohol breath test.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100035, China

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Institute of Clinical Pharmacology, Director of the Clinical Trial Center, and Director of the Department of Pharmacy, Peking University

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: March 4, 2025
• Study Start: May 13, 2024
• Primary Completion: June 28, 2024
• Study Completion: September 23, 2024
• Last Updated: March 4, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)