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NEXUS STUDY: A STUDY TO TEST SINGLE AND MULTIPLE DOSES OF MER511 GIVEN TO ADULTS WITH GRAVES' DISEASE

NCT ID: NCT07305818

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2028-07-24

Brief Summary

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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.

Detailed Description

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This Phase 1, first-in-human, multicenter study will evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of single and multiple ascending doses of MER511 administered to adults (18 to 55 years of age, inclusive) with GD (Graves' disease).

The study will consist of 2 sequential parts: a single ascending dose (SAD) part (Part A) followed by a multiple ascending dose (MAD) part (Part B).

Part A will employ a placebo-controlled, sponsor-open, participant- and investigator-blind design to evaluate the safety, tolerability, PK, PD, and immunogenicity of single ascending intravenous doses and a single subcutaneous dose of MER511.

Part B will employ a placebo-controlled, sponsor-open, participant- and investigator-blind design to assess the safety, tolerability, PK, PD, and immunogenicity of multiple subcutaneous doses of MER511.

Conditions

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Graves Disease

Keywords

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Graves' Disease, Hyperthyroidism, Basedow disease, Exophthalmic goitre, TSHR, Autoimmune, Anti-thyroid drugs, Autoimmune thyroid disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The study will enroll cohorts of participants who will be assigned to a dose group for Part A and Part B.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Sponsor-open label, participant- and investigator-blind (Masked)

Study Groups

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Part A (SAD) MER511 IV

For Cohorts 1-7 , each cohort participant will receive a single ascending dose of MER511 via IV administration on Day 1

Group Type EXPERIMENTAL

MER511 (IV)

Intervention Type BIOLOGICAL

Participants will receive a single dose of MER511 on Day 1

Part A (SAD) placebo IV

For Cohorts 1-7, each cohort participant will receive a single dose of placebo via IV administration on Day 1

Group Type PLACEBO_COMPARATOR

Placebo comparator (IV)

Intervention Type BIOLOGICAL

Participants will receive a single dose of Placebo on Day 1

Part A (SAD) MER511 SC

For Cohort 8, participants will receive a single dose of MER511 (determined from Cohort 1-7) via SC administration on Day 1

Group Type EXPERIMENTAL

MER511 (SC)

Intervention Type BIOLOGICAL

Participants will receive a single dose of MER511 on Day 1

Part A (SAD) placebo SC

For Cohort 8, participants will receive a single dose of placebo (determined from Cohort 1-7) via SC administration on Day 1

Group Type PLACEBO_COMPARATOR

Placebo comparator (SC)

Intervention Type BIOLOGICAL

Participants will receive a single dose of Placebo on Day 1

Part B (MAD) MER511 SC

Up to 3 cohorts of participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29

Group Type EXPERIMENTAL

MER511 (SC) for MAD

Intervention Type BIOLOGICAL

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

- Part B (MAD) placebo SC

Up to 3 cohorts of participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29

Group Type PLACEBO_COMPARATOR

Placebo comparator (SC) for MAD

Intervention Type BIOLOGICAL

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

Interventions

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MER511 (IV)

Participants will receive a single dose of MER511 on Day 1

Intervention Type BIOLOGICAL

Placebo comparator (IV)

Participants will receive a single dose of Placebo on Day 1

Intervention Type BIOLOGICAL

MER511 (SC)

Participants will receive a single dose of MER511 on Day 1

Intervention Type BIOLOGICAL

Placebo comparator (SC)

Participants will receive a single dose of Placebo on Day 1

Intervention Type 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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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. 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merida Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site # 1101

Hollywood, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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2025-523823-23-00

Identifier Type: CTIS

Identifier Source: secondary_id

MER511-1001

Identifier Type: -

Identifier Source: org_study_id