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

NCT03945318 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2026-06-16

No results posted yet for this study

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

Interventions

DRUG

BION-1301 Single Dose

A single IV infusion infusion of BION-1301 at doses ranging from 10 to 1350 mg, administered once

DRUG

Placebo Single Dose

A single IV infusion of placebo

DRUG

BION-1301 Multiple Doses

Part 2: Multiple IV infusions of BION 1301 administered every 2 weeks (Q2W) at doses of 50 mg, 150 mg or 450 mg for up to 3 doses. Part 3: Repeated dosing of BION 1301: 450 mg IV Q2W for ≥24 weeks followed by 600 mg SC Q2W, or 600 mg SC Q2W throughout.

DRUG

Placebo Multiple Doses

Multiple IV infusions of placebo administered every 2 weeks for up to 3 doses

DRUG

BION-1301 Single Dose

600 mg SC injection every 2 weeks (Q2W) for retreatment, administered via vials or pre-filled syringes (PFS)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-08
Primary Completion
2026-06-10
Completion
2026-06-10
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03945318 on ClinicalTrials.gov