Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Inclusion Criteria

• Body mass index (BMI) ≤50 kg/m2, inclusive
• Diagnosis of clinically active moderate-to-severe HS (Hurley Stage 2 or 3)
• Total abscess or inflammatory nodule (AN) count of ≥5, affecting at least 2 distinct anatomic regions, with at least 1 accessible AN of adequate size for biopsy (diameter > 1 cm)
• Total draining tunnel (dT) count of ≤20
• Documented history of inadequate response or intolerance to at least a 3-month course of 1 conventional systemic therapy (e.g., antibiotic) and 1 biologic drug (e.g., adalimumab or secukinumab)
• Doses of medications for HS must be stable for at least 5 weeks prior to study drug administration
• Must agree to use highly effective method of contraception for at least 1 year post SBT777101 administration

Exclusion Criteria

• Major surgery within 12 weeks prior to screening or planned within 12 months after dosing
• History of or current inflammatory or other autoimmune disease
• Complex presentations of HS
• Skin disease other than HS that may confound clinical assessments or increase subject risk in the study
• Uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease
• Active current infection or history of recurrent infections
• Active or untreated latent tuberculosis
• Primary or secondary immunodeficiency