A Phase 1 interventional study of BHV-1300 in Graves Disease, sponsored by Biohaven Therapeutics Ltd.. Recruiting at 18 sites in 2 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Biohaven Therapeutics Ltd. · Phase 1, Interventional, and Treatment
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.
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 15 is below the median of 60 across 104 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
1. Participants must have serologically confirmed Graves' Disease.
Key Exclusion Criteria:
Drug: BHV-1300
BHV-1300 is delivered subcutaneously (SC)
Number 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 52 weeks).
Time frame: Baseline to Week 52
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 52
Started Aug 2025 (actual). Primary completion is estimated for Sep 2027, 25 months after the start.
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Studies of the drug tested here: BHV-1300
Biohaven Therapeutics Ltd.