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

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

Last updated 2026-04-20

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 solution for IV infusion administered as a single dose.

DRUG

Placebo Single Dose

A solution by IV infusion administered as a single dose.

DRUG

BION-1301 Multiple Doses

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

DRUG

Placebo Multiple Doses

A solution by IV infusion administered as multiple doses.

DRUG

BION-1301 Single Dose

SC injection administration as a single dose using vials or pre-filled syringes (PFS) (Part 4 only).

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
2026-04-30
Completion
2026-04-30
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