The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
BHV-1300 is delivered subcutaneously (SC)
Site-103
South Gate, California, United States
RECRUITINGSite-100
Miami, Florida, United States
RECRUITINGNumber of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 12 weeks).
Time frame: Baseline to Week 12
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
Time frame: Baseline to Week 12
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Site-104
Columbus, Georgia, United States
Site-106
Houston, Texas, United States
RECRUITINGSite-101
Houston, Texas, United States
RECRUITINGSite-105
Shavano Park, Texas, United States
RECRUITINGSite-004
Fitzroy, Australia
RECRUITINGSite-001
Kotara, Australia
RECRUITINGSite-003
Melbourne, Australia
RECRUITINGSite-008
Parkville, Australia
RECRUITING...and 2 more locations