NCT03945318

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2019-04-08
• Primary completion: 2025-10-01
• Completion: 2026-04-13
• First posted: 2019-05-10
• Last updated: 2025-04-13

Locations

16 sites across 3 countries: United States, South Korea, United Kingdom

Regulatory

• FDA-regulated drug study