Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria

Sponsor

Alexion Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05314231

Collaborator

(none)

Enrollment

Location

Arm

8.1

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Proteinuria	Drug: ALXN1720	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 29, 2022

Anticipated Primary Completion Date :

Jan 23, 2023

Anticipated Study Completion Date :

Mar 3, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ALXN1720

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

Drug: ALXN1720

All enrolled participants will receive a single dose of ALXN1720 on Day 1 followed by a Post-treatment and Follow-up Period (92 days).

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Documented diagnosis of Lupus Nephritis, IgA Nephropathy, Primary Membranous Nephropathy, Focal Segmental Glomerulosclerosis, Diabetic Nephropathy, or Hypertensive Nephrosclerosis
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

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.