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
Location: See all (15) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Adults 18 to 65 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).
Locations
United States
California
Site # 1111
RECRUITING
Torrance
Florida
Site # 1101
RECRUITING
Hollywood
Site # 1112
RECRUITING
Miami
Site # 1109
RECRUITING
Wesley Chapel
Massachusetts
Site # 1107
RECRUITING
Boston
Minnesota
Site # 1102
RECRUITING
Rochester
North Carolina
Site # 1106
RECRUITING
Morehead City
Ohio
Site # 1104
RECRUITING
Columbus
Pennsylvania
Site # 1108
RECRUITING
Philadelphia
Texas
Site # 1113
RECRUITING
Desoto
Site # 1105
RECRUITING
Webster
Other Locations
Spain
Site # 2205
RECRUITING
A Coruña
Site # 2204
RECRUITING
Barcelona
Site # 2206
RECRUITING
Barcelona
Site # 2201
RECRUITING
Seville
Contact Information
Primary
Clinical Operations
clinicaltrials@meridabio.com
+1 339-255-3030
Time Frame
Start Date:2025-12-19
Estimated Completion Date:2028-07-24
Participants
Target number of participants:100
Treatments
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