Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03945318
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : October 14, 2020
Sponsor:
Information provided by (Responsible Party):
Aduro Biotech, Inc.

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 Intervention/treatment Phase
IgA Nephropathy Drug: BION-1301 Single Dose Drug: Placebo Single Dose Drug: BION-1301 Multiple Doses Drug: Placebo Multiple Doses 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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)
Masking Description: Parts 1 and 2 will be performed in a double-blind manner, for clinical research personnel interacting with study subjects. An unblinded pharmacist will prepare the doses of investigational study drugs.
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 8, 2019
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

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.

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.

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.




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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 10 weeks after the final dose of study drug)
  3. Males must agree to follow the protocol-specified contraception guidance throughout the study (from Screening through 10 weeks 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03945318


Locations
Layout table for location information
United States, California
National Institute of Clinical Research Phase One Recruiting
Garden Grove, California, United States, 92844
Contact: Clinical Trial Team    714-462-2000    nicr@nicresearch.com   
Principal Investigator: Ajit Sawhney, MD         
Amicis Research Center Recruiting
Northridge, California, United States, 91324
Contact: Mia Quinn    818-924-4708    mia.quinn@amicisresearch.com   
Principal Investigator: Billy Hour, MD         
California Research Foundation Recruiting
San Diego, California, United States, 92123
Contact: Donald Brandon, MD    619-291-2321    dbrandon@crftrials.com   
Principal Investigator: Donald M Brandon, MD         
California Kidney Specialists Recruiting
San Dimas, California, United States, 91773
Contact: Aamir Jamal, MD    800-797-1695    info@nariresearch.com   
Principal Investigator: Aamir Jamal, MD         
Nephrology Educational Services and Research Recruiting
Tarzana, California, United States, 91356
Contact: Ahmed Alsabounchi    818-668-3111    ahmedalsabounchi@nmamd.com   
Principal Investigator: Kenneth Kleinman, MD         
Desert Cities Dialysis - Amethyst Recruiting
Victorville, California, United States, 92392
Contact: Jessy McCollum    760-998-2068    jmccollum@nicresearch.com   
Principal Investigator: Jay Shankar, MD         
United States, Texas
MedResearch Inc. Recruiting
El Paso, Texas, United States, 79935
Contact: Blanca Mendoza    915-307-4669    bmendoza@epmedresearch.com   
Principal Investigator: German Hernandez, MD         
Texas Research Institute Recruiting
Fort Worth, Texas, United States, 76104
Contact: Mano Ellappan    817-870-2616    mellappan@ppghealthcare.com   
Principal Investigator: Saravanan Balamuthusamy, MD         
United Kingdom
PAREXEL Early Phase Clinical Unit Completed
London, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Aduro Biotech, Inc.
Layout table for additonal information
Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03945318    
Other Study ID Numbers: ADU-CL-19
2018-003360-31 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases