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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease

A Phase 1, First-in-Human, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Intravenous and Subcutaneous Administration of MER511 in Adults With Graves' Disease

NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease (NCT07305818) is a Phase 1 interventional studying Graves Disease, sponsored by Merida Biosciences. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Graves Disease, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 100 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Graves Disease subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Adults 18 to 55 years of age, inclusive, at the time of signing the ICF 2. Documented GD diagnosis, 3. Receiving stable dose of ATD (Antithyroid drug) 4. Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive 5. Women of childbearing potential must agree to use highly effective contraceptive methods 6. Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence 7. Signed willing to sign a consent form to participate in the study 8. Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments). Who Should NOT Join This Trial: 1. History of: 1. total thyroidectomy. 2. History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter). 3. History of thyroid storm. 4. 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 2. Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis. 3. Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening. 4. History of active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening 5. History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation. 6. Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing. 7. Active systemic autoimmune conditions (where your immune system attacks your own body) requiring treatment that causes undue risk in the opinion of the investigator. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Adults 18 to 55 years of age, inclusive, at the time of signing the ICF 2. Documented GD diagnosis, 3. Receiving stable dose of ATD (Antithyroid drug) 4. Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive 5. Women of childbearing potential must agree to use highly effective contraceptive methods 6. Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence 7. Signed informed consent to participate in the study 8. Willingness and ability, in the opinion of the investigator, to comply with protocol requirements and restrictions (eg, dosing, schedule of assessments). Exclusion Criteria: 1. History of: 1. total thyroidectomy. 2. History of hyperthyroidism not caused by GD (eg, toxic adenoma, toxic multinodular goiter). 3. History of thyroid storm. 4. 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 2. Likely to require definitive treatment for GD (RAI therapy or thyroidectomy) during the study, based on GD history and anticipated prognosis. 3. Use of levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks prior to Screening. 4. History of active or chronic moderate-to-severe TED per EUropean Group On Graves' Orbitopathy (EUGOGO) criteria as judged by the investigator at Screening 5. History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation. 6. Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing. 7. Active systemic autoimmune disease requiring treatment that causes undue risk in the opinion of the investigator. 8. History of cardiovascular, respiratory, renal, gastrointestinal, endocrinological (other than GD), hematological, immunodeficiency, or neurological disorders that may constitute a risk when taking the IMP or interfere with data interpretation. 9. History of liver disease 10. Pregnant, breastfeeding, or planning to become pregnant during the study 11. Treatment with prohibited medications prior to planned IMP dosing or likely to require prohibited concomitant therapy during the study 12. Live vaccine(s) or mRNA vaccine(s) within 1 month prior to IMP dosing, or plans to receive such vaccines during the study 13. Treatment with any investigational drug within 6 months prior to enrollment 14. Total IgG level \<700 mg/dL at Screening 15. Any of the following at Screening (confirmed by single repeat measurement, if deemed necessary): * ALT or AST \>1.5 × ULN * Total bilirubin \>1.5 × ULN 16. Estimated glomerular filtration rate (eGFR) \<85 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation 17. Positive result for HIV antibody, HBsAg, or hepatitis C antibody with detectable viral RNA levels at Screening 18. Positive drug screen or positive test for alcohol 19. 12-lead ECG demonstrating any of the following at Screening: * QTcF interval \>450 ms * QRS interval \>120 ms * PR interval \>220 ms 20. Blood pressure measurements demonstrating any of the following at Screening: * Systolic blood pressure ≥140 mmHg * Diastolic blood pressure ≥90 mmHg 21. Heart rate \<45 bpm or \>100 bpm 22. Donated more than 500 mL of blood in the 2 months prior to signing the ICF 23. Current enrollment or past participation within 30 days or 5 half-lives (whichever is longer) prior to signing the ICF in any other clinical trial involving an IMP 24. Refusal to adhere to lifestyle considerations as defined in the protocol 25. Employee of the investigator, clinic, or sponsor with direct involvement in the proposed study or other studies under the direction of the investigator or clinic, as well as family members of the employee or investigator 26. Any other conditions that, in the opinion of the investigator or the sponsor, could interfere with participation in or completion of the study 27. Part B only: anyone who received IMP during Part A of the study

Treatments Being Tested

BIOLOGICAL

MER511 (IV)

Participants will receive a single dose of MER511 on Day 1

BIOLOGICAL

Placebo comparator (IV)

Participants will receive a single dose of Placebo on Day 1

BIOLOGICAL

MER511 (SC)

Participants will receive a single dose of MER511 on Day 1

BIOLOGICAL

Placebo comparator (SC)

Participants will receive a single dose of Placebo on Day 1

BIOLOGICAL

MER511 (SC) for MAD

Participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29

BIOLOGICAL

Placebo comparator (SC) for MAD

Participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Site # 1103
Phoenix, Arizona, United States
Site # 1101
Hollywood, Florida, United States
Site # 1102
Rochester, Minnesota, United States
Site # 1104
Columbus, Ohio, United States
Site # 1108
Philadelphia, Pennsylvania, United States
Site # 1105
Webster, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07305818), the sponsor (Merida Biosciences), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07305818 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07305818?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07305818?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07305818. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07305818. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.