About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03945318

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted December 22, 2020

Study Description

Brief 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).

  • Condition or Disease:IgA Nephropathy
  • Intervention/Treatment: Drug: BION-1301 Single Dose
    Drug: Placebo Single Dose
    Drug: BION-1301 Multiple Doses
    Drug: Placebo Multiple Doses
  • Phase: Phase 1
Detailed Description

This is a Phase 1 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 subjects with IgAN. The study will enroll up to 72 healthy subjects and up to 20 subjects with IgAN.

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 92 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: Part 1 (SAD-HV) is a randomized, placebo-controlled single ascending dose design in HVs. Part 2 (MAD-HV): is a randomized, placebo-controlled multiple ascending dose design in HVs. Part 3 (MD-IgAN) is an open-label multiple dose design in subjects with IgAN.
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: June 2022
  • Estimated Study Completion Date: July 2022
Arms and interventions
Arm Intervention/treatment
Experimental: Part 1: BION-1301
Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion.
Drug: BION-1301 Single Dose
A solution for IV infusion administered as a single dose.
Placebo Comparator: Part 1: Placebo
Subjects will receive a single dose of placebo administered by IV infusion.
Drug: Placebo Single Dose
A solution by IV infusion administered as a single dose.
Experimental: Part 2: BION-1301
Up to 4 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion.
Drug: BION-1301 Multiple Doses
A solution for IV infusion administered as multiple doses.
Experimental: Part 3: BION-1301
Up to 2 cohorts of subjects will receive multiple doses of BION-1301 at a dose and frequency to be determined by IV infusion.
Drug: BION-1301 Multiple Doses
A solution for IV infusion administered as multiple doses.
Placebo Comparator: Part 2: Placebo
Subjects will receive placebo by IV infusion.
Drug: Placebo Multiple Doses
A solution by IV infusion administered as multiple doses.
Outcome Measures
  • Primary Outcome Measures: 1. Incidence of Treatment Emergent Adverse Events (TEAEs) as assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) [ Time Frame: Subjects followed from date of enrollment until the end of study, assessed up to 24 weeks. ]
  • 2. Severity of TEAEs as assessed according to NCI-CTCAE [ Time Frame: Subjects followed from date of enrollment until the end of study, assessed up to 24 weeks. ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

Inclusion Criteria for Healthy Volunteers:

1. Healthy male or female volunteers, 18 to 55 years old

2. Females must be of non-childbearing potential

3. Males must agree to follow the protocol-specified contraception guidance

4. Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg

5. Non-smoker, defined as an individual who has not smoked previously and/or who has
discontinued smoking or the use of nicotine/nicotine-containing products at least 3
months before Screening

6. Able to provide signed informed consent

Exclusion Criteria for Healthy Volunteers:

1. Regular consumption of alcohol within 6 months prior to Screening, or use of soft
drugs (such as marijuana) within 3 months prior to Screening, or hard drugs (such as
cocaine and phencyclidine) within 1 year prior to Screening and/or positive blood or
urine test results for drugs of abuse or alcohol at Screening or Admission

2. Donated blood in the 3 months prior to the first dose of study drug, plasma in the 7
days prior to the first dose of study drug, or platelets in the 6 weeks prior to the
first dose of study drug

3. History or evidence of a clinically significant disorder, condition, or disease that
could pose a risk to subject safety or interfere with the study, or would make the
subject unsuitable for participation, eg, respiratory, renal, hepatic,
gastrointestinal, hematological, lymphatic, neurological, cardiovascular, or
psychiatric disease

4. Female who is breastfeeding or who has a positive serum pregnancy test at Screening or
a positive urine pregnancy test on Day -1

Inclusion Criteria for Adults with IgAN:

1. Male or female ≥18 years old at Screening

2. Women of child-bearing potential (WOCBP; per CTFG 2014) must agree to follow the
protocol-specified contraception guidance throughout the study (from Screening through
approximately 5 and1/2 months after the final dose of study drug)

3. Males must agree to follow the protocol-specified contraception guidance throughout
the study (from Screening through approximately 5 and 1/2 months after the final dose
of study drug)

4. BMI between 18 and 35 kg/m^2, inclusive, at Screening with a weight of at least 50 kg

5. Diagnosis of IgAN verified by biopsy taken within the past 10 years

6. Urine protein ≥ 0.5 g/24h; OR UPCR ≥ 0.5 g/g (or ≥ 50 mg/mmol)

7. eGFR (per Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) or
measured GFR > 45 mL/min per 1.73 m^2; OR 30-45 mL/min per 1.73 m^2 if kidney biopsy
performed within 2 years prior to Day 1 does not provide evidence of fibrosis

8. Stable on an optimized dose of angiotensin converting enzyme (ACE) inhibitors and/or
angiotensin-receptor blockers (ARBs) for at least 3 months prior to Screening

Exclusion Criteria for Adults with IgAN:

1. Known or suspected allergy or hypersensitivity to any component of BION-1301, or
history of severe hypersensitivity reaction to any monoclonal antibody

2. Donated blood in the 3 months prior to the first dose of study drug; plasma in the 7
days prior to the first dose of study drug; or platelets in the 6 weeks prior to the
first dose of study drug

3. Participated in any other study in which receipt of an investigational new drug, or
investigational device occurred within 28 days, or 5 half-lives (whichever is longer)
of first dose of study drug in the present study

4. Secondary forms of IgAN as defined by the treating physician (eg, Henoch-Schönlein
purpura patients and those with associated alcoholic cirrhosis)

5. Presence of crescent formation in ≥50% of glomeruli assessed on renal biopsy

6. Received systemic corticosteroid therapy (> 10 mg/day of prednisone or equivalent) or
any other form of immunosuppressive therapy within 3 months prior to the first dose of
study drug

Contacts and Locations
Contacts
Locations
Show 11 Study Locations
Sponsors and Collaborators

Chinook Therapeutics, Inc.

More Information
  • Responsible Party: Chinook Therapeutics, Inc.
  • ClinicalTrials.gov Identifier: NCT03945318 History of Changes
  • Other Study ID Numbers: ADU-CL-19, 2018-003360-31
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: December 22, 2020
  • Last Verified: December 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Additional relevant MeSH terms: Kidney Diseases Glomerulonephritis, IGA