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

NCT07305818 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: MER511-10012025-523823-23-00
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Graves Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with TEAEs (Treatment-emergent adverse events)

  Adverse events that start or worsen in severity after the start of study drug will be categorized as TEAEs

  - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24

• Number of participants with clinically significant changes in ECGs, vital signs, clinical laboratory values, and physical examination

  Incidence of clinically significant abnormalities in ECGs, vital signs, clinical laboratory values, and physical examination

  - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24

Secondary Outcomes (5)

• Serum Cmax (Maximum observed concentration)

  - Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) through Week 16- Part B (MAD) Cohorts: Day 1 (Week 0 dosing Day) Through Week 24

• Serum tmax (Time to maximum concentration)

  - Part A (SAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 16 - Part B (MAD) Cohorts: Day 1 (Week 0 dosing day) Through Week 24

• Serum AUCinf (area under concentration-time curve from time zero to infinity)

  Part A (SAD) Only: Day 1 (Week 0) Dosing Through Week 16

• Serum AUC0-tau (area under concentration-time curve during the dosing interval)

  Part B (MAD) Only: Day 1 (Week 0) Dosing Through Week 24

• Number of participants with ADAs (Anti-drug antibody)

  - Part A (SAD) Cohorts: Day 1 (Week 0) Dosing Through Week 16 or Early Discontinuation - Part B (MAD) Cohorts: Day 1 (Week 0) Dosing Through Week 24

Study Arms (6)

Part A (SAD) MER511 IV

EXPERIMENTAL

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

Biological: MER511 (IV)

Part A (SAD) placebo IV

PLACEBO COMPARATOR

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

Biological: Placebo comparator (IV)

Part A (SAD) MER511 SC

EXPERIMENTAL

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

Biological: MER511 (SC)

Part A (SAD) placebo SC

PLACEBO COMPARATOR

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

Biological: Placebo comparator (SC)

Part B (MAD) MER511 SC

EXPERIMENTAL

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

Biological: MER511 (SC) for MAD

- Part B (MAD) placebo SC

PLACEBO COMPARATOR

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

Biological: Placebo comparator (SC) for MAD

Interventions

MER511 (IV) BIOLOGICAL

Participants will receive a single dose of MER511 on Day 1

Part A (SAD) MER511 IV

MER511 (SC) BIOLOGICAL

Participants will receive a single dose of MER511 on Day 1

Part A (SAD) MER511 SC

Placebo comparator (IV) BIOLOGICAL

Participants will receive a single dose of Placebo on Day 1

Part A (SAD) placebo IV

Placebo comparator (SC) BIOLOGICAL

Participants will receive a single dose of Placebo on Day 1

Part A (SAD) placebo SC

MER511 (SC) for MAD 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) MER511 SC

Placebo comparator (SC) for MAD BIOLOGICAL

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

- Part B (MAD) placebo SC

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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
• 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
• History of TED-directed medical treatment (including IV/oral steroids, immunosuppressants, or teprotumumab), surgical treatment, and/or orbital radiation.
• Major surgery or use of iodinated contrast within 3 months prior to planned IMP dosing.
• Active systemic autoimmune disease requiring treatment that causes undue risk in the opinion of the investigator.
• 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.
• History of liver disease
• Pregnant, breastfeeding, or planning to become pregnant during the study
• Treatment with prohibited medications prior to planned IMP dosing or likely to require prohibited concomitant therapy during the study

Sponsors & Collaborators

• Merida Biosciences: lead

Study Sites (7)

Site # 1103

Phoenix, Arizona, 85053, United States

RECRUITING

Site # 1101

Hollywood, Florida, 33024, United States

RECRUITING

Site # 1107

Boston, Massachusetts, 02114, United States

RECRUITING

Site # 1102

Rochester, Minnesota, 55905, United States

RECRUITING

Site # 1104

Columbus, Ohio, 43203, United States

RECRUITING

Site # 1108

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Site # 1105

Webster, Texas, 77598, United States

RECRUITING

MeSH Terms

Conditions

Graves Disease; Hyperthyroidism

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Clinical Operations

CONTACT

+1 339-255-3030; clinicaltrials@meridabio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Sponsor-open label, participant- and investigator-blind (Masked)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will enroll cohorts of participants who will be assigned to a dose group for Part A and Part B.

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: December 26, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): July 24, 2028
• Study Completion (Estimated): July 24, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)