BION-1301 for IgA Nephropathy

Recruiting at 28 trial locations

Overseen By Aamir Jamal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Chinook Therapeutics, Inc.

Trial Summary

What is the purpose of this trial?

Multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BION-1301 in healthy volunteers and adults with IgA Nephropathy (IgAN).

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Adults with IgA Nephropathy (IgAN) who have had a kidney biopsy in the last 10 years, protein in urine, and stable kidney function. They must be non-smokers, not pregnant or breastfeeding, not using drugs or alcohol excessively, and agree to use contraception. Healthy volunteers aged 18-55 with a BMI of 18-35 kg/m^2 can also participate.

Inclusion Criteria

I have not smoked or used nicotine products for at least 3 months.

I agree to follow the study's rules for birth control for 6 months after the last dose.

I am 18 years old or older.

Exclusion Criteria

I do not have any major health issues that could make this study unsafe for me.

Participated in any other study in which receipt of an investigational new drug, or investigational device occurred within 28 days, or 5 half-lives (whichever is longer) of first dose of study drug in the present study

You have regularly consumed alcohol, used marijuana in the last 3 months, or used hard drugs like cocaine and phencyclidine in the last year. If a blood or urine test shows that you have used drugs or alcohol, you may be excluded from the study.

Treatment Details

Interventions

• BION-1301 (Monoclonal Antibodies)

Trial Overview The trial is testing BION-1301's safety and effects on the body compared to a placebo. It involves giving either one dose or multiple doses of BION-1301/placebo to see how it's tolerated by healthy people and those with IgAN.

Participant Groups

Group I: Part 4 Retreatment: BION-1301 Experimental Treatment 1 Intervention

Eligible participants from Part 3 may enroll in Part 4 due to disease progression or by choice for optional retreatment and receive SC injection at 600mg/biweekly.

Group II: Part 3: BION-1301 Experimental Treatment 1 Intervention

Two cohorts of participants will receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly.

Group III: Part 2: BION-1301 Experimental Treatment 1 Intervention

Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion.

Group IV: Part 1: BION-1301 Experimental Treatment 1 Intervention

Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion.

Group V: Part 1: Placebo Placebo Group 1 Intervention

Participants will receive a single dose of placebo administered by IV infusion.

Group VI: Part 2: Placebo Placebo Group 1 Intervention

Participants will receive placebo by IV infusion.

Who Is Running the Clinical Trial?

Chinook Therapeutics, Inc.

Lead Sponsor

Trials

10

Recruited

1,100+