Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03945318
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 103 participants
Conditions and interventions
Conditions
Interventions
- BION-1301 Single Dose Drug
- Placebo Single Dose Drug
- BION-1301 Multiple Doses Drug
- Placebo Multiple Doses Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
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
- Jun 9, 2026
- Completion
- Jun 9, 2026
- Last update posted
- Jun 15, 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 Jun 15, 2026 · Synced Sep 9, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03945318 live on ClinicalTrials.gov.