Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Phase 1

Completed

• Conditions: Proteinuria
• Interventions: Drug: ALXN1720

• Registration Number: NCT05314231
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Study Start: 2022-06-29
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ALXN1720	ALXN1720	Participants will receive a single dose of ALXN1720, given as a SC infusion at a dose of 1500 mg.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Clinical Trial Site 2; 🇰🇷 Anyang-Si, Gyeonggi-do, Korea, Republic of

Clinical Trial Site 1; 🇰🇷 Seoul, Korea, Republic of