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

NCT07449156 | Not Yet Recruiting Phase 1

• 1 other identifier: HB0043-AV-0-01
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Investigator's global assessment (IGA) - percentage of subjects with improvement

  Week 2, 4, 8, 12, 16

• Change in inflammatory lesion counts

  Week 16

• Investigator's global assessment (IGA) - percentage of subjects with improvement

  Week 2, 4, 8, 12, 16

• Investigator's global assessment (IGA) - percentage of subjects with improvement

  Week 2, 4, 8, 12, 16

• Incidence of AEs and serious adverse events (SAEs))

  Baseline to week 16

Study Arms (2)

HB0043

EXPERIMENTAL

Participants randomized to Arm 1 will receive HB0043 via subcutaneous injection biweekly from Week 0 to Week 14.

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.

Drug: HB0043; Drug: Placebo

Interventions

HB0043 DRUG

300mg

HB0043; Placebo

Placebo DRUG

300mg

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.

You may not qualify if:

• \. 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.
• \. 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.

Sponsors & Collaborators

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

Study Sites (1)

Dermatology Hospital affiliated to Shandong First Medical University,

Jinan, Shandong, China

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 4, 2026
• Study Start: March 27, 2026
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): March 27, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Locations

CN (1)