BION-1301 Multiple Doses for Glomerulonephritis, IGA

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Glomerulonephritis, IGA+2 More
BION-1301 Multiple Doses - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study the effects of BION-1301 in healthy volunteers and adults with IgA Nephropathy. The safety, tolerability, and how the body processes and responds to the drug will be evaluated.

Eligible Conditions
  • Glomerulonephritis, IGA
  • IgA Nephropathy (IgAN)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Glomerulonephritis, IGA

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Subjects followed from date of enrollment until the end of study, assessed up to 76 weeks.

Week 76
Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Severity of TEAEs as assessed according to NCI-CTCAE

Trial Safety

Safety Progress

1 of 3

Other trials for Glomerulonephritis, IGA

Trial Design

5 Treatment Groups

Part 3: BION-1301
1 of 5
Part 1: BION-1301
1 of 5
Part 2: BION-1301
1 of 5
Part 1: Placebo
1 of 5
Part 2: Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

112 Total Participants · 5 Treatment Groups

Primary Treatment: BION-1301 Multiple Doses · Has Placebo Group · Phase 1 & 2

Part 3: BION-1301
Drug
Experimental Group · 1 Intervention: BION-1301 Multiple Doses · Intervention Types: Drug
Part 1: BION-1301
Drug
Experimental Group · 1 Intervention: BION-1301 Single Dose · Intervention Types: Drug
Part 2: BION-1301
Drug
Experimental Group · 1 Intervention: BION-1301 Multiple Doses · Intervention Types: Drug
Part 1: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Single Dose · Intervention Types: Drug
Part 2: Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo Multiple Doses · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: subjects followed from date of enrollment until the end of study, assessed up to 76 weeks.

Who is running the clinical trial?

Chinook Therapeutics, Inc.Lead Sponsor
5 Previous Clinical Trials
197 Total Patients Enrolled
1 Trials studying Glomerulonephritis, IGA
20 Patients Enrolled for Glomerulonephritis, IGA
Alan Glicklich, M.D.Study DirectorChinook Therapeutics, Inc.
2 Previous Clinical Trials
480 Total Patients Enrolled
2 Trials studying Glomerulonephritis, IGA
480 Patients Enrolled for Glomerulonephritis, IGA
Charlotte Jones-Burton, M.D.Study DirectorChinook Therapeutics, Inc.
2 Previous Clinical Trials
136 Total Patients Enrolled
1 Trials studying Glomerulonephritis, IGA
100 Patients Enrolled for Glomerulonephritis, IGA

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 2nd, 2021

Last Reviewed: October 17th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.