Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
- Conditions
- IgA Nephropathy
- Interventions
- Drug: BION-1301 Single DoseDrug: Placebo Single DoseDrug: BION-1301 Multiple DosesDrug: Placebo Multiple Doses
- Registration Number
- NCT03945318
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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).
- Detailed Description
This is a Phase 1/2 study of BION-1301, a first-in-class humanized IgG4 anti-a proliferation-inducing ligand (APRIL) monoclonal antibody.
The study will be conducted in three parts. Part 1: double-blind, randomized, placebo-controlled, single ascending dose (SAD) in healthy volunteers (HVs). Part 2: double-blind, randomized, placebo-controlled multiple ascending dose (MAD) in HVs. Part 3: Open-label, multiple dose (MD) in participants with IgAN. Part 4: Retreatment period
Parts 1 and 2 have been completed. Part 3 enrollment is complete. Part 4 enrollment is open for eligible participants from Part 3.
The study will enroll up to 40 participants with IgAN.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 103
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: BION-1301 BION-1301 Single Dose Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion. Part 1: Placebo Placebo Single Dose Participants will receive a single dose of placebo administered by IV infusion. Part 2: BION-1301 BION-1301 Multiple Doses Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion. Part 2: Placebo Placebo Multiple Doses Participants will receive placebo by IV infusion. Part 3: BION-1301 BION-1301 Multiple Doses Two cohorts of participants will receive multiple doses of BION-1301 by IV infusion (Cohort 1) or SC injection (Cohort 2) at 600mg/biweekly. Part 4 Retreatment: BION-1301 BION-1301 Single Dose 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.
- Primary Outcome Measures
Name Time Method Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Participants followed from date of enrollment until the end of study, assessed up to 76 weeks. Severity of TEAEs as assessed according to NCI-CTCAE Participants followed from date of enrollment until the end of study, assessed up to 76 weeks.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
Chris Sholer, P.C.
🇺🇸Oklahoma City, Oklahoma, United States
Amicis Research Center
🇺🇸Northridge, California, United States
New York Nephrology
🇺🇸Clifton Park, New York, United States
Liberty Research Center
🇺🇸Dallas, Texas, United States
Prolato Clinical Research Center
🇺🇸Houston, Texas, United States
Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Chungcheongnamdo, Korea, Republic of
Hanyang University Guri Hostpital
🇰🇷Guri-si, Gyeonggi-do, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang-Si, Gyeonggi-Do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Liverpool University Hospital NHS Foundation Trust
🇬🇧Liverpool, England, United Kingdom
PAREXEL Early Phase Clinical Unit
🇬🇧London, United Kingdom
Colorado Kidney Care, P.C.
🇺🇸Denver, Colorado, United States
Nephrology Associates of Central Florida
🇺🇸Orlando, Florida, United States
Elixia Tampa, LLC
🇺🇸Tampa, Florida, United States