A Phase 1/2, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy

Who is this study for? Patients with IgA Nephropathy
What treatments are being studied? BION-1301
Status: Active_not_recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Healthy male or female volunteers, 18 to 55 years old

• Females must be of non-childbearing potential

• Males must agree to follow the protocol-specified contraception guidance

• Body mass index (BMI) between 18 and 35 kg/m\^2, with a weight of at least 50 kg

• Non-smoker, defined as an individual who has not smoked previously and/or who has discontinued smoking or the use of nicotine/nicotine-containing products at least 3 months before Screening

• Able to provide signed informed consent

• Male or female ≥18 years old at Screening

• Women of child-bearing potential (WOCBP; per CTFG 2014) must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug)

• Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through approximately 6 months after the final dose of study drug)

• BMI between 18 and 40 kg/m\^2, inclusive, at Screening with a weight of at least 50 kg

• Diagnosis of IgAN verified by biopsy taken within the past 10 years

• Urine protein ≥ 0.5 g/24h; OR UPCR ≥ 0.5 g/g (or ≥ 50 mg/mmol)

• eGFR (per Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) or measured GFR ≥ 30 mL/min per 1.73 m\^2

• Stable on an optimized dose of angiotensin converting enzyme (ACE) inhibitors and/or angiotensin-receptor blockers (ARBs) for at least 3 months prior to Screening or intolerant to ACE/ARB

Locations
United States
California
Amicis Research Center
Northridge
Colorado
Colorado Kidney Care, P.C.
Denver
Florida
Nephrology Associates of Central Florida
Orlando
Elixia Tampa, LLC
Tampa
New York
New York Nephrology
Clifton Park
Oklahoma
Chris Sholer, P.C.
Oklahoma City
Texas
Liberty Research Center
Arlington
Liberty Research Center
Dallas
Prolato Clinical Research Center
Houston
Other Locations
Republic of Korea
Hallym University Sacred Heart Hospital
Anyang-si
Soon Chun Hyang University Hospital Cheonan
Cheonan
National Health Insurance Service Ilsan Hospital
Goyang-si
Hanyang University Guri Hostpital
Guri-si
Seoul National University Bundang Hospital
Seongnam-si
United Kingdom
Liverpool University Hospital NHS Foundation Trust
Liverpool
PAREXEL Early Phase Clinical Unit
London
Time Frame
Start Date: 2019-04-08
Completion Date: 2026-04-13
Participants
Target number of participants: 103
Treatments
Experimental: Part 1: BION-1301
Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion.
Placebo_comparator: Part 1: Placebo
Participants will receive a single dose of placebo administered by IV infusion.
Experimental: Part 2: BION-1301
Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion.
Placebo_comparator: Part 2: Placebo
Participants will receive placebo by IV infusion.
Experimental: Part 3: BION-1301
Two cohorts of participants will receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly.
Experimental: Part 4 Retreatment: BION-1301
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.
Related Therapeutic Areas
Sponsors
Leads: Chinook Therapeutics, Inc.

This content was sourced from clinicaltrials.gov