NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Dis… (NCT07305818) | Clinical Trial Compass
RecruitingPhase 1
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
United States100 participantsStarted 2025-12-19
Plain-language summary
The purpose of this study is to evaluate how well MER511 is tolerated and what side effects may occur in adults who have Graves' disease. The study drug will be administered either intravenously (into a vein in the arm) or subcutaneously (under the skin).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Adults 18 to 55 years of age, inclusive, at the time of signing the ICF
✓. Documented GD diagnosis,
✓. Receiving stable dose of ATD (Antithyroid drug)
✓. Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive
✓. Women of childbearing potential must agree to use highly effective contraceptive methods
✓. Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence
✓. Signed informed consent to participate in the study
✓. Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments).
Exclusion criteria
✕. History of:
✕. total thyroidectomy.
✕. History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter).
✕. History of thyroid storm.
✕. History of agranulocytosis, anemia, leukopenia, thrombocytopenia, vasculitis, or liver toxicity due to prior ATD therapy Treatment with RAI therapy within 12 months prior to Screening
What they're measuring
1
Number of participants with TEAEs (Treatment-emergent adverse events)
Timeframe: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
2
Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination
Timeframe: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
✕. Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis.
✕. Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening.
✕. History of active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening