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A Phase 1, First-in-Human, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Intravenous and Subcutaneous MER511 in Adults With Graves' Disease
Led by Merida Biosciences · Updated on 2026-05-28
100
Participants Needed
8
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, how the body processes, and immune response to single and multiple doses of MER511 in adults with Graves' disease. This Phase 1, first-in-human, multicenter study focuses on adults aged 18 to 55 years diagnosed with Graves' disease. The study aims to monitor side effects and understand how MER511 behaves in the body. The study has two parts: Part A tests single ascending doses of MER511 given intravenously or subcutaneously compared to placebo, while Part B assesses multiple ascending doses given subcutaneously or placebo. Participants in Part A receive a single dose on Day 1, while those in Part B receive doses on Day 1 and Day 29. Different cohorts receive varying doses to evaluate safety and drug effects. Participants will have blood tests to track drug levels and immune responses, along with monitoring of vital signs, ECGs, and physical exams to detect side effects. Safety is followed for up to 16 weeks in Part A and 24 weeks in Part B. Researchers will measure treatment-emergent adverse events and clinically significant changes from baseline throughout the study, ensuring detailed evaluation of MER511's tolerability and impact.
CONDITIONS
Brief Title
NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 55 years at the time of consent
- Documented diagnosis of Graves' disease
- Receiving a stable dose of antithyroid drug
- Body weight at least 50 kg (110 lb) and BMI between 18.0 and 35.0 kg/m2
- Women of childbearing potential agree to use highly effective contraception
- Men with partners of childbearing potential or who are pregnant agree to use condom or strict abstinence
- Signed informed consent
- Willing and able to comply with study requirements and schedule
You will not qualify if you...
- History of total thyroidectomy
- History of hyperthyroidism not caused by Graves' disease
- History of thyroid storm
- History of blood disorders or liver toxicity due to previous antithyroid drug therapy
- Treatment with radioactive iodine therapy within 12 months before screening
- Likely need for definitive Graves' disease treatment during the study
- Use of levothyroxine, desiccated thyroid extract, or T3 within 6 weeks before screening
- History of active or moderate-to-severe thyroid eye disease
- History of thyroid eye disease treatment including steroids, immunosuppressants, surgery, or radiation
- Major surgery or use of iodinated contrast within 3 months before dosing
- Active systemic autoimmune disease requiring treatment posing risk
- Significant cardiovascular, respiratory, renal, gastrointestinal, endocrine (other than Graves' disease), hematological, immunodeficiency, or neurological disorders
- History of liver disease
- Pregnant, breastfeeding, or planning pregnancy during the study
- Use or likely need of prohibited medications during the study
- Recent live or mRNA vaccines within 1 month before dosing or planned during study
- Treatment with investigational drugs within 6 months before enrollment
- Low total IgG level at screening
- Elevated liver enzymes or bilirubin beyond set limits at screening
- Reduced kidney function below defined limit
- Positive tests for HIV, hepatitis B or C with detectable viral RNA
- Positive drug or alcohol screens
- Abnormal ECG readings beyond defined limits
- High blood pressure or abnormal heart rate readings
- Recent blood donation exceeding 500 mL within 2 months
- Participation in another investigational drug trial within 30 days or 5 half-lives
- Refusal to follow lifestyle requirements
- Employment or family relation to study staff with direct involvement
- Other conditions interfering with study participation
- For Part B: prior participation in Part A of this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks depending on study part
Participants receive either single or multiple doses of MER511 or placebo via intravenous or subcutaneous administration depending on their assigned cohort.
Dosing on Day 1 and Day 29 with multiple assessments up to Week 24
Duration - Up to 16 weeks for single dose part; up to 24 weeks for multiple dose part
Participants are monitored for safety, tolerability, and pharmacokinetics after treatment ends.
Regular visits for assessments up to Week 16 or Week 24 depending on part
Trial Site Locations
Total: 8 locations
1
Site # 1103
Phoenix, Arizona, United States, 85053
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2
Site # 1101
Hollywood, Florida, United States, 33024
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3
Site # 1109
Wesley Chapel, Florida, United States, 33544
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4
Site # 1107
Boston, Massachusetts, United States, 02114
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5
Site # 1102
Rochester, Minnesota, United States, 55905
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6
Site # 1104
Columbus, Ohio, United States, 43203
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7
Site # 1108
Philadelphia, Pennsylvania, United States, 19107
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8
Site # 1105
Webster, Texas, United States, 77598
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Research Team
C
Clinical Operations
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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