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
Merida Biosciences
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.
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…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adults 18 to 55 years of age, inclusive, at the time of signing the ICF 2. Documented GD diagnosis, 3. Receiving stable dose of ATD (Antithyroid drug) 4. Body weight at least 50 kg (110 lb) and body mass index (BMI) 18.0-35.0 kg/m2, inclusive 5. Women of childbearing potential must agree to use highly effective contraceptive methods 6. Men with partners of childbearing potential or who are pregnant must agree to use a condom or strict abstinence 7. Signed informed consent to participate in the study 8. Willingness and ability, in the opinion of the investigator, to comp…
Interventions
- BiologicalMER511 (IV)
Participants will receive a single dose of MER511 on Day 1
- BiologicalPlacebo comparator (IV)
Participants will receive a single dose of Placebo on Day 1
- BiologicalMER511 (SC)
Participants will receive a single dose of MER511 on Day 1
- BiologicalPlacebo comparator (SC)
Participants will receive a single dose of Placebo on Day 1
- BiologicalMER511 (SC) for MAD
Participants will receive multiple ascending doses of MER511 via SC administration assigned for their cohort on Day 1 and Day 29
- BiologicalPlacebo comparator (SC) for MAD
Participants will receive multiple doses of placebo via SC administration assigned for their cohort on Day 1 and Day 29
Locations (7)
- Site # 1103Phoenix, Arizona
- Site # 1101Hollywood, Florida
- Site # 1107Boston, Massachusetts
- Site # 1102Rochester, Minnesota
- Site # 1104Columbus, Ohio
- Site # 1108Philadelphia, Pennsylvania