Healthy Adult SubjectsPhase 1NCT06857799
A Study on the Safety, Tolerability and Pharmacokinetics of WS-0101 Tablets in Chinese Healthy Subjects
A Phase 1 study testing Light Power Density and Light Duration 40 mW/cm²*1000s and Light Power Density and Light Duration 80 mW/cm²*1000s in people with Healthy Adult Subjects, run by Peking University First Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Subjects
- What is being tested?
- Light Power Density and Light Duration 40 mW/cm²*1000s and Light Power Density and Light Duration 80 mW/cm²*1000s
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2024to 23 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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))/(0.81Serum 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.
- Smoking more than 5 cigarettes per day within 3 months prior to screening, or an inability to comply with the study's smoking restrictions.
- Daily consumption of more than 6 servings of caffeine (e.g., coffee, tea, cola, energy drinks) within 3 months prior to screening, or consumption of caffeine-containing products within 24 hours prior to dosing.
- Participation in another clinical trial within the past 3 months.
- Recent or planned surgery within the study period.
- Receipt of a vaccine within 30 days prior to screening, or a planned vaccine during the study.
- Blood donation or significant blood loss (≥400 mL) within 1 month prior to screening, or planned blood donation during the study.
- Inability to tolerate venipuncture for blood collection, or a history of fainting or phobias related to blood draws.
- Unwillingness to assist with photographic documentation of the application site.
- Any other condition or circumstance deemed by the investigator to make participation in the study inappropriate.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University First Hospital
Beijing, Beijing Municipality, 100035
About this study
Official title: 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
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.
Read the 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
- 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.
- 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.
- 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.
- 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
- Being tested
- Light Power Density and Light Duration 40 mW/cm²*1000s, Light Power Density and Light Duration 80 mW/cm²*1000s
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light Power Density and Light Duration 40 mW/cm²*1000sProcedure or surgery
Use light power density and light duration 40 mW/cm²*1000s treatment
Light Power Density and Light Duration 80 mW/cm²*1000sProcedure or surgery
Use light power density and light duration 80 mW/cm²*1000s treatment
| Study group | Role | What they receive |
|---|---|---|
| 5% WS-0101/Placebo | Active comparator | Treat with 5% WS-0101 medication or placebo. Receives: 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. Receives: 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. Receives: Procedure: Light Power Density and Light Duration 80 mW/cm²*1000s |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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.
Measured: Visit 6 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start13 May 2024
- Primary completion28 Jun 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult SubjectsStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Yimin, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06857799
- Sponsor's protocol ID
- HS_WS-0101_101
- Status last verified
- May 2024
- First submitted
- 11 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06857799
- Acronym / sponsor ID
- HS_WS-0101_101
- Conditions
- Healthy Adult Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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.
- 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.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5% WS-0101/Placebo | Active comparator | Procedure: Light Power Density and Light Duration 40 mW/cm²*1000s, Procedure: Light Power Density and Light Duration 80 mW/cm²*1000sTreat with 5% WS-0101 medication or placebo. |
| 10% WS-0101/Placebo | Active comparator | Procedure: Light Power Density and Light Duration 40 mW/cm²*1000s, Procedure: Light Power Density and Light Duration 80 mW/cm²*1000sTreat with 10% WS-0101 medication or placebo. |
| 20% WS-0101/Placebo | Active comparator | Procedure: Light Power Density and Light Duration 80 mW/cm²*1000sTreat with 20% WS-0101 medication or placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Subjects must meet the following criteria to be included in this study:
Key exclusion criteria (24 listed)
- Subjects meeting any of the following criteria will be excluded from the study:
- Alternatively: Ccr=((140-Age)Weight(Kg)(0.85 for women))/(0.81Serum creatinine (μmol/dL))
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light Power Density and Light Duration 40 mW/cm²*1000sUse light power density and light duration 40 mW/cm²*1000s treatment | Procedure or surgery | 10% WS-0101/Placebo, 5% WS-0101/Placebo |
| Light Power Density and Light Duration 80 mW/cm²*1000sUse light power density and light duration 80 mW/cm²*1000s treatment | Procedure or surgery | 10% WS-0101/Placebo, 20% WS-0101/Placebo, 5% WS-0101/Placebo |
Primary outcome
To evaluate the safety and tolerability of different topical doses of WS-0101, followed by varying light power densities, in healthy adult subjects
Time frame: Visit 11 (Day14)
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
1 secondary outcome
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
Time frame: Visit 6 (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Light Power Density and Light Duration 40 mW/cm²*1000s and Light Power Density and Light Duration 80 mW/cm²*1000s in people with Healthy Adult Subjects, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety and tolerability of different topical doses of WS-0101, followed by varying light power densities, in healthy adult subjects (time frame: Visit 11 (Day14)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.