NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease
NCT07305818 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-04-24
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
Interventions
- 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
- 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
Sponsors & Collaborators
-
Merida Biosciences
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-19
- Primary Completion
- 2028-07-24
- Completion
- 2028-07-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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