A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: HB0043; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 21
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Dermatology Hospital affiliated to Shandong First Medical University,
      • Contact: Wu Wu; Phone Number: +86-15040367023; Email: xueqiong.wu@huaota.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HB0043; Participants randomized to Arm 1 will receive HB0043 via subcutaneous injection biweekly from Week 0 to Week 14.	Drug: HB0043; 300mg
Experimental: Placebo; 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.	Drug: HB0043; 300mg; Drug: Placebo; 300mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammatory lesion counts	Absolute change from Baseline in the number of inflammatory acne lesions	Week 16
Investigator's global assessment (IGA) - change from Baseline	Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	Week 2, 4, 8, 12, 16
Change in inflammatory lesion counts	Percentage change from Baseline in the number of inflammatory acne lesions	Week 16
Investigator's global assessment (IGA) - percentage of subjects with improvement	Percentage of subjects with an IGA score of "clear" or "almost clear"	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.	Week 2, 4, 8, 12, 16
Incidence of AEs and serious adverse events (SAEs))	Incidence of AEs and SAEs	Baseline to week 16

Collaborators and Investigators

• Sponsor: Shanghai Huaota Biopharmaceutical Co., Ltd.
• Collaborators: Dermatology Hospital affiliated to Shandong First Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): March 27, 2026
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): March 27, 2027

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Skin and Connective Tissue Diseases; Acne Vulgaris
• Other Study ID Numbers: HB0043-AV-0-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No