Safety and Efficacy Study of BDB-001 Injection in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)

A Multicenter, Randomized, Double-blind, Placebo Parallel-controlled, Phase I/II Study to Explore Safety and Efficacy of BDB-001 Injection in Subjects With Moderate to Severe Hidradenitis Suppurativa

A study to explore the safety and efficacy of treatment with BDB-001 Injection in adults with moderate to severe hidradenitis suppurativa (HS).

Inclusion Criteria:

• 18 years old≤Age≤65 years old, male or female;
• Diagnosis of HS for at least 6 months;
• HS lesions must be present in at least two distinct anatomical areas, one of which must be at least located in the apocrine sweat gland area and Hurley Stage II or Hurley Stage III;
• Total abscess and inflammatory nodule (AN) count of ≥ 3.

Exclusion Criteria:

• Subject was previously treated with adalimumab or another biologic product during the 3 months before the first administration;
• Subject received any oral antibiotic treatment for HS within 2 weeks before the first administration;
• Subject received any oral retinoids treatment for HS within 4 weeks before the first administration;
• Subject received oral opioids analgesics within 1 week before the first administration;
• Systematic treatment with glucocorticoid or intramural injection within 4 weeks before the first administration;
• History of heart disease or malignancy.