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).

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07449156

Enrollment

Registered

2026-03-04

Start date

2026-03-27

Completion date

2027-03-27

Last updated

2026-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acne Vulgaris

Brief summary

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).

Interventions

DRUGHB0043

300mg

DRUGPlacebo

300mg

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Investigator's global assessment (IGA) - percentage of subjects with improvement	Week 2, 4, 8, 12, 16	Percentage of subjects with at least two-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) \[scores: 0-4; 0=clear, 4=severe\]
Change in inflammatory lesion counts	Week 16	Percentage change from Baseline in the number of inflammatory acne lesions
Incidence of AEs and serious adverse events (SAEs))	Baseline to week 16	Incidence of AEs and SAEs

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026