Actinic Keratosis (AK)Phase 1NCT07318675
A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
A Phase 1 study testing HW211026 in people with Actinic Keratosis (AK), run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. at 1 site in China.
Trial summary
This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis (AK)
- What is being tested?
- HW211026
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.
- A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the nostrils, and the inner ear canal).
- Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study.
Who cannot join
- Subjects with any of the following conditions within the treatment field：
- Presence of clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns;
- Maximum diameter of a single lesion > 2 cm；
- History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors；
- Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation.
- treatment field falls within any of the following locations:
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- Presence of incompletely healed wounds within a 5 cm radius of the treatment field;
- Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within a 5 cm radius of the treatment field.
- Subjects with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere with the assessment of safety or efficacy.
- Subjects with severe cardiovascular and cerebrovascular diseases.
- Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening.
- Receipt of any topical intervention for actinic keratosis on the administration area within 3 months prior to screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Skin Disease Hospital
Shanghai, 200443
Guolong Zhang, Doctor, +87 021 36803156, zglamu@163.com
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis
This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.
- Conditions
- Actinic Keratosis (AK)
- Being tested
- HW211026, Placebo
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HW211026Drug
Dose 1 and Dose 2
PlaceboDrug
Dose 1 and Dose 2
| Study group | Role | What they receive |
|---|---|---|
| HW211026 | Experimental | Single or multiple topical doses of HW211026 Receives: Drug: HW211026 |
| Placebo | Placebo comparator | Single or multiple topical doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of treatment emergent adverse events (TEAEs)
To assess the safety and tolerability of single or multiple topical doses of HW211026 in adults with actinic keratosis
Measured: up to 28 days
Secondary outcomes (4)
The maximum serum concentration(Cmax)
PK Parameter
Measured: up to 10 days
The Area Under the Curve from dosing to the time of the last measured concentration
PK Parameter
Measured: up to 10 days
The time to reach Cmax(Tmax)
PK Parameter
Measured: up to 10 days
The Half life(t1/2)
PK Parameter
Measured: up to 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start25 Dec 2025
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic Keratosis (AK)Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07318675
- Sponsor's protocol ID
- HW211026-102
- Status last verified
- Jan 2026
- First submitted
- 16 Dec 2025
- Last updated
- 6 Jan 2026
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT07318675
- Acronym / sponsor ID
- HW211026-102
- Conditions
- Actinic Keratosis (AK)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Dec 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 6 Jan 2026 (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 is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HW211026 | Experimental | Drug: HW211026Single or multiple topical doses of HW211026 |
| Placebo | Placebo comparator | Drug: PlaceboSingle or multiple topical doses of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.
- A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the nostrils, and the inner ear canal).
- Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study.
Key exclusion criteria (12 listed)
- Subjects with any of the following conditions within the treatment field：
- treatment field falls within any of the following locations:
- Subjects with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere with the assessment of safety or efficacy.
- Subjects with severe cardiovascular and cerebrovascular diseases.
- Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening.
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 |
|---|---|---|
| HW211026Dose 1 and Dose 2 | Drug | HW211026 |
| PlaceboDose 1 and Dose 2 | Drug | Placebo |
Primary outcome
The number and severity of treatment emergent adverse events (TEAEs)
Time frame: up to 28 days
To assess the safety and tolerability of single or multiple topical doses of HW211026 in adults with actinic keratosis
4 secondary outcomes
The maximum serum concentration(Cmax)
Time frame: up to 10 days
The Area Under the Curve from dosing to the time of the last measured concentration
Time frame: up to 10 days
The time to reach Cmax(Tmax)
Time frame: up to 10 days
The Half life(t1/2)
Time frame: up to 10 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- 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.
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 HW211026 in people with Actinic Keratosis (AK), run by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 6 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number and severity of treatment emergent adverse events (TEAEs) (time frame: up to 28 days). 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 6 Jan 2026.