NCT07305818

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Merida Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Graves Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-19
• Primary completion: 2028-07-24
• Completion: 2028-07-24
• First posted: 2025-12-26
• Last updated: 2026-03-30

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study