NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
ConditionGraves Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorMerida Biosciences
About this trial
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.
Eligibility criteria
Qualifiers
Adults 18 to 65 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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MER511 (IV)
- Placebo comparator (IV)
- MER511 (SC)
- Placebo comparator (SC)
- MER511 (SC) for MAD
- Placebo comparator (SC) for MAD
Treatment groups
100 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov