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

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ClinicalTrials.gov Identifier: NCT03945318
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : May 10, 2019
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 63 healthy subjects and up to 10 subjects with IgAN.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 73 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 2020
Estimated Study Completion Date : November 2020

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 3 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
Subjects will receive multiple doses of BION-1301 at a dose 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 29 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 29 weeks. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Healthy Volunteers:

  • Healthy male or female volunteers, 18 to 55 years old
  • Females must be of non-childbearing potential
  • Males must agree to follow the protocol-specified contraception guidance
  • Body mass index (BMI) between 18 and 35 kg/m^2, with a weight of at least 50 kg
  • 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
  • Able to provide signed informed consent

Exclusion Criteria for Healthy Volunteers:

Healthy volunteers who meet any of the following exclusion criteria will not be eligible to participate:

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

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


Contacts
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Contact: Muna Albayaty, MBChB, FFPM muna.albayaty@parexel.com

Locations
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United Kingdom
PAREXEL Early Phase Clinical Unit Recruiting
London, United Kingdom, HA1 3UJ
Contact: Muna Albayaty, MBChB, FFPM       muna.albayaty@parexel.com   
Sponsors and Collaborators
Aduro Biotech, Inc.

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Responsible Party: Aduro Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03945318     History of Changes
Other Study ID Numbers: ADU-CL-19
2018-003360-31 ( EudraCT Number )
First Posted: May 10, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Kidney Diseases
Glomerulonephritis, IGA
Urologic Diseases
Glomerulonephritis
Nephritis
Autoimmune Diseases
Immune System Diseases