Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Study Overview
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Brief Summary
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The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.

Official Title
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A Phase 1b, Open-Label, Single-Dose Pharmacokinetic Study of Subcutaneous ALXN1720 in Adult Participants With Varying Degrees of Proteinuria

Conditions
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Proteinuria

Intervention / Treatment
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* Drug: ALXN1720


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy or Membranoproliferative Glomerulonephritis (all forms). Other cause of kidney disease may be included per investigator agreement with the Sponsor Proteinuria >=1 based on absolute amount in grams per day (g/d) as measured in one complete and valid 24-hour urine collection during Screening Body weight ≥ 40 kg at Screening Exclusion Criteria: Kidney transplant Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 during Screening Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study. Treatment with complement inhibitors at any time. Treatment with rituximab within 6 months before initiation of study drug on Day 1; or, planned treatment with rituximab within 3 months after initiation of study drug on Day 1. Participation in another investigational drug or investigational device study within 30 days before initiation of study drug on Day 1 in this study or within 5 half-lives of that investigational product, whichever is greater.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALXN1720<br>Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg. | Drug: ALXN1720<br>* All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Concentration of ALXN1720 |  | Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Treatment-Emergent Adverse Events |  | Day 1 (Predose) through Follow-up (Day 92) | 
| Serum Concentration of Free and Total Complement Component 5 (C5) |  | Day 1 (0.5 hours predose and postdose) and postdose on Days 2, 3, 8, 15, 29, 43, and 57 | 
| Number of Participants With Antidrug Antibodies (ADAs) to ALXN1720 |  | Day 1 (predose) through Day 57 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Proteinuria, Glomerular Disease, Chronic Kidney Disease, Lupus Nephritis, Immunoglobulin A Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, Hypertensive Nephrosclerosis, Minimal Change Disease, Thin Basement Membrane Nephropathy, Membranoproliferative Glomerulonephritis (all forms)