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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
SLUCare Academic Pavillion
RECRUITING
St Louis
North Carolina
Duke University
RECRUITING
Durham
New York
Columbia University Irving Medical Center
RECRUITING
New York
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Contact Information
Primary
Sabrina Fox-Bosetti, MPH
clinicaloperations@sonomabio.com
415-992-6245
Backup
Jason Do
clinicaloperations@sonomabio.com
415-992-6245
Time Frame
Start Date: 2024-10-09
Estimated Completion Date: 2026-11
Participants
Target number of participants: 24
Treatments
Experimental: SBT777101 Dose Level 1
Low dose SBT777101
Experimental: SBT777101 Dose Level 2
Mid dose SBT777101
Experimental: SBT777101 Dose Level 3
High dose SBT777101
Related Therapeutic Areas
Sponsors
Leads: Sonoma Biotherapeutics, Inc.

This content was sourced from clinicaltrials.gov

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