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.
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 65 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Participants will receive a single dose of MER511 on Day 1
Participants will receive a single dose of Placebo on Day 1
Participants will receive a single dose of MER511 on Day 1
Site # 1111
Torrance, California, United States
RECRUITINGSite # 1101
Hollywood, Florida, United States
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
Time frame: - 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
Time frame: - Part A (SAD) Cohorts: Day 1 up to Week 16 - Part B (MAD) Cohorts: Day 1 up to Week 24
Serum Cmax (Maximum observed concentration)
Measurement of the maximum observed concentration
Time frame: - 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)
Measurement of the time to maximum observed concentration
Time frame: - 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)
Measurement of area under concentration-time curve from time zero to infinity
Time frame: Part A (SAD) Only: Day 1 (Week 0) Dosing Through Week 16
Serum AUC0-tau (area under concentration-time curve during the dosing interval)
Measurement of area under concentration-time curve during the dosing interval
Time frame: Part B (MAD) Only: Day 1 (Week 0) Dosing Through Week 24
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Participants will receive a single dose of Placebo on Day 1
Participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29
Participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29
Site # 1112
Miami, Florida, United States
RECRUITINGSite # 1109
Wesley Chapel, Florida, United States
RECRUITINGSite # 1107
Boston, Massachusetts, United States
RECRUITINGSite # 1102
Rochester, Minnesota, United States
RECRUITINGSite # 1106
Morehead City, North Carolina, United States
RECRUITINGSite # 1104
Columbus, Ohio, United States
RECRUITINGSite # 1108
Philadelphia, Pennsylvania, United States
RECRUITINGSite # 1113
DeSoto, Texas, United States
RECRUITING...and 5 more locations
Number of participants with ADAs (Anti-drug antibody)
Blood samples will be collected to evaluate the immunogenicity of MER511 in participants with GD (Graves' disease)
Time frame: - 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