Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Description

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

Conditions

Hidradenitis Suppurativa

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Study Overview

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Study Details

Study overview

This study will test the safety and effects of SBT777101 when given as a single dose to subjects with hidradenitis suppurativa. Increasing dose levels will be given after the safety at lower dose levels is shown.

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Activity of Single Ascending Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Study of Single Doses of SBT777101 in Subjects With Hidradenitis Suppurativa

Condition
Hidradenitis Suppurativa
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Saint Louis

SLUCare Academic Pavillion, Saint Louis, Missouri, United States, 63110

Durham

Duke University, Durham, North Carolina, United States, 27708

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sonoma Biotherapeutics, Inc.,

Joseph Arron, MD PhD, STUDY_DIRECTOR, Sonoma Biotherapeutics, Inc.

Study Record Dates

2026-11