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

Conditions

• Graves Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• MER511 (IV) — BIOLOGICAL
  Participants will receive a single dose of MER511 on Day 1
• Placebo comparator (IV) — BIOLOGICAL
  Participants will receive a single dose of Placebo on Day 1
• MER511 (SC) — BIOLOGICAL
  Participants will receive a single dose of MER511 on Day 1
• Placebo comparator (SC) — BIOLOGICAL
  Participants will receive a single dose of Placebo on Day 1
• 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
• 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

Study Details

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.

Key Dates

Start date

Dec 19, 2025

Status verified

May 2026

Primary completion

Jul 24, 2028

Completion

Jul 24, 2028

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: 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
• Placebo Comparator: 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
• Experimental: 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
• Placebo Comparator: 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
• Experimental: 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
• Placebo Comparator: - 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

Primary Outcome Measure

Number of participants with TEAEs (Treatment-emergent adverse events) [ Time Frame: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24 ]

Central Contacts

• Clinical Operations
  +1 339-255-3030
  [email protected]

Locations (8)

Find similar trials in Phoenix, AZ

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