ClinicalTrials.gov record
Active, not recruiting Phase 1Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT03945318

Public ClinicalTrials.gov record NCT03945318. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 11:13 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Study identification

NCT ID
NCT03945318
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
103 participants

Conditions and interventions

Interventions

  • BION-1301 Multiple Doses Drug
  • BION-1301 Single Dose Drug
  • Placebo Multiple Doses Drug
  • Placebo Single Dose Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 7, 2019
Primary completion
Apr 29, 2026
Completion
Apr 29, 2026
Last update posted
Apr 19, 2026

2019 – 2026

United States locations

U.S. sites
9
U.S. states
6
U.S. cities
9
Facility City State ZIP Site status
Amicis Research Center Northridge California 91324
Colorado Kidney Care, P.C. Denver Colorado 80230
Nephrology Associates of Central Florida Orlando Florida 32806
Elixia Tampa, LLC Tampa Florida 33618
New York Nephrology Clifton Park New York 12065
Chris Sholer, P.C. Oklahoma City Oklahoma 73116
Liberty Research Center Arlington Texas 76012
Liberty Research Center Dallas Texas 75230
Prolato Clinical Research Center Houston Texas 77054

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03945318, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 19, 2026 · Synced Apr 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03945318 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →