Acne VulgarisPhase 1/2NCT07449156
A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.
A Phase 1/2 study testing HB0043 in people with Acne Vulgaris, run by Shanghai Huaota Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- HB0043
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2026to 27 Mar 2027
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosed with mild to moderate facial acne vulgaris; 4. Throughout the study period, participants must refrain from using concomitant acne therapies.
- 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.
Who cannot join
- 1. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.
- 3. Participant has any facial skin disease other than common acne. 4. Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 5. Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris; 6. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 7. History of recurrent or recent serious infection; 8. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 9. Pregnant or lactating women; 10. Any reason why, in the opinion of the investigator, the patient should not participate.
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
Dermatology Hospital affiliated to Shandong First Medical University,
Jinan, Shandong
Wu Wu, +86-15040367023, xueqiong.wu@huaota.com
About this study
Official title: A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Acne Vulgaris (AV).
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
Read the detailed description
The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).
- Conditions
- Acne Vulgaris
- Being tested
- HB0043, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HB0043Drug
300mg
PlaceboDrug
300mg
| Study group | Role | What they receive |
|---|---|---|
| HB0043 | Experimental | Participants randomized to Arm 1 will receive HB0043 via subcutaneous injection biweekly from Week 0 to Week 14. Receives: Drug: HB0043 |
| Placebo | Experimental | Participants randomized to Arm 2 will receive placebo via subcutaneous injection biweekly from Week 0 to Week 6, followed by HB0043 via subcutaneous injection biweekly from Week 8 to Week 14. Receives: Drug: HB0043; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammatory lesion counts
Absolute change from Baseline in the number of inflammatory acne lesions
Measured: Week 16
Investigator's global assessment (IGA) - change from Baseline
Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
Measured: Week 16
Secondary outcomes (5)
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with at least two-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) [scores: 0-4; 0=clear, 4=severe]
Measured: Week 2, 4, 8, 12, 16
Change in inflammatory lesion counts
Percentage change from Baseline in the number of inflammatory acne lesions
Measured: Week 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with an IGA score of "clear" or "almost clear"
Measured: Week 2, 4, 8, 12, 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Percentage of subjects with an IGA score of "clear" or "almost clear" and a reduction of at least two-grade compared to the baseline IGA score.
Measured: Week 2, 4, 8, 12, 16
Incidence of AEs and serious adverse events (SAEs))
Incidence of AEs and SAEs
Measured: Baseline to week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start27 Mar 2026 (estimated)
- Primary completion27 Oct 2026 (estimated)
- Study completion27 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Shanghai Huaota Biopharmaceutical Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Hospital affiliated to Shandong First Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449156
- Sponsor's protocol ID
- HB0043-AV-0-01
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Acne Vulgaris (AV).
- ClinicalTrials.gov ID
- NCT07449156
- Acronym / sponsor ID
- HB0043-AV-0-01
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- Shanghai Huaota Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Dermatology Hospital affiliated to Shandong First Medical University
- Study start
- 27 Mar 2026 (estimated)
- Primary completion
- 27 Oct 2026 (estimated)
- Study completion
- 27 Mar 2027 (estimated)
- First posted
- 4 Mar 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.
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
Detailed description
The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HB0043 | Experimental | Drug: HB0043Participants randomized to Arm 1 will receive HB0043 via subcutaneous injection biweekly from Week 0 to Week 14. |
| Placebo | Experimental | Drug: HB0043, Drug: PlaceboParticipants randomized to Arm 2 will receive placebo via subcutaneous injection biweekly from Week 0 to Week 6, followed by HB0043 via subcutaneous injection biweekly from Week 8 to Week 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosed with mild to moderate facial acne vulgaris; 4. Throughout the study period, participants must refrain from using concomitant acne therapies.
- 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.
Key exclusion criteria (2 listed)
- 1. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.
- 3. Participant has any facial skin disease other than common acne. 4. Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 5. Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris; 6. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 7. History of recurrent or recent serious infection; 8. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 9. Pregnant or lactating women; 10. Any reason why, in the opinion of the investigator, the patient should not participate.
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 |
|---|---|---|
| HB0043300mg | Drug | HB0043, Placebo |
| Placebo300mg | Drug | Placebo |
Primary outcome
Change in inflammatory lesion counts
Time frame: Week 16
Absolute change from Baseline in the number of inflammatory acne lesions
Investigator's global assessment (IGA) - change from Baseline
Time frame: Week 16
Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
5 secondary outcomes
Investigator's global assessment (IGA) - percentage of subjects with improvement
Time frame: Week 2, 4, 8, 12, 16
Change in inflammatory lesion counts
Time frame: Week 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Time frame: Week 2, 4, 8, 12, 16
Investigator's global assessment (IGA) - percentage of subjects with improvement
Time frame: Week 2, 4, 8, 12, 16
Incidence of AEs and serious adverse events (SAEs))
Time frame: Baseline to week 16
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 4 Mar 2026.
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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.
Dermatology Hospital affiliated to Shandong First Medical University,
Jinan, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HB0043 in people with Acne Vulgaris, run by Shanghai Huaota Biopharmaceutical Co., Ltd. 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 2 inclusion and 2 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: opening soon, as of the sponsor's last update on 4 Mar 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in inflammatory lesion counts (time frame: Week 16). The study lists 2 primary outcomes in all. 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 2026.