Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

NCT03945318 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: CFUB523A121032018-003360-31
• Study Type: interventional
• Target: 103
• Locations: 3 countries
• Sites: 16

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).

Conditions

IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (6)

Part 1: BION-1301

EXPERIMENTAL

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

Drug: BION-1301 Single Dose

Part 1: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Single Dose

Part 2: BION-1301

EXPERIMENTAL

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

Drug: BION-1301 Multiple Doses

Part 2: Placebo

PLACEBO COMPARATOR

Participants will receive placebo by IV infusion.

Drug: Placebo Multiple Doses

Part 3: BION-1301

EXPERIMENTAL

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

Drug: BION-1301 Multiple Doses

Part 4 Retreatment: BION-1301

EXPERIMENTAL

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.

Drug: BION-1301 Single Dose

Interventions

BION-1301 Single Dose DRUG

A solution for IV infusion administered as a single dose.

Part 1: BION-1301

Placebo Single Dose DRUG

A solution by IV infusion administered as a single dose.

Part 1: Placebo

BION-1301 Multiple Doses DRUG

A solution for IV infusion or SC injections (Part 3 only) administered as multiple doses.

Part 2: BION-1301; Part 3: BION-1301

Placebo Multiple Doses DRUG

A solution by IV infusion administered as multiple doses.

Part 2: Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Regular consumption of alcohol within 6 months prior to Screening, or use of soft drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or urine test results for drugs of abuse or alcohol at Screening or Admission
• Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7 days prior to the first dose of study drug, or platelets in the 6 weeks prior to the first dose of study drug
• History or evidence of a clinically significant disorder, condition, or disease that could pose a risk to subject safety or interfere with the study, or would make the subject unsuitable for participation, eg, respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or psychiatric disease
• Female who is breastfeeding or who has a positive serum pregnancy test at Screening or a positive urine pregnancy test on Day -1
• 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
• Known or suspected allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody
• Donated blood in the 3 months prior to the first dose of study drug; plasma in the 7 days prior to the first dose of study drug; or platelets in the 6 weeks prior to the first dose of study drug
• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

Amicis Research Center

Northridge, California, 91324, United States

Location

Colorado Kidney Care, P.C.

Denver, Colorado, 80230, United States

Location

Nephrology Associates of Central Florida

Orlando, Florida, 32806, United States

Location

Elixia Tampa, LLC

Tampa, Florida, 33618, United States

Location

New York Nephrology

Clifton Park, New York, 12065, United States

Location

Chris Sholer, P.C.

Oklahoma City, Oklahoma, 73116, United States

Location

Liberty Research Center

Arlington, Texas, 76012, United States

Location

Liberty Research Center

Dallas, Texas, 75230, United States

Location

Prolato Clinical Research Center

Houston, Texas, 77054, United States

Location

Soon Chun Hyang University Hospital Cheonan

Cheonan, Chungcheongnam-do, 31151, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang-si, Gyeonggi-do, 10444, South Korea

Location

Hanyang University Guri Hostpital

Guri-si, Gyeonggi-do, 11923, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Liverpool University Hospital NHS Foundation Trust

Liverpool, England, L7 8XP, United Kingdom

Location

PAREXEL Early Phase Clinical Unit

London, HA1 3UJ, United Kingdom

Location

Related Publications (1)

• Kooienga L, Lo J, Lee EY, Kim SG, Thomas H, Workeneh B, Agha I, Song Y, Smith W, van Eenennaam H, Van Elsas A, Dulos J, Barratt J. Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy. Kidney Int. 2025 Sep;108(3):445-454. doi: 10.1016/j.kint.2025.05.006. Epub 2025 Jun 5.

  PMID: 40482854 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Parts 1 and 2 will be performed in a double-blind manner, for clinical research personnel interacting with study participants. An unblinded pharmacist will prepare the doses of investigational study drugs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 (SAD-HV) is a randomized, placebo-controlled single ascending dose design in HVs. Part 2 (MAD-HV): is a randomized, placebo-controlled multiple ascending dose design in HVs. Part 3 (MD-IgAN) is an open-label multiple dose design in participants with IgAN. Part 4 (IgAN) is open-label retreatment for Part 3 participants.

Study Record Dates

• First Submitted: April 21, 2019
• First Posted: May 10, 2019
• Study Start: April 8, 2019
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (9); GB (2); KR (5)