Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    BION-1301

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 : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Aduro Biotech, Inc.

Tracking Information
First Submitted Date  ICMJE April 21, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date May 10, 2019
Actual Study Start Date  ICMJE April 8, 2019
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2019)
  • 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. ]
  • 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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
Official Title  ICMJE A Phase 1, Multicenter Trial to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy
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).
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE 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
Condition  ICMJE IgA Nephropathy
Intervention  ICMJE
  • Drug: BION-1301 Single Dose
    A solution for IV infusion administered as a single dose.
  • Drug: Placebo Single Dose
    A solution by IV infusion administered as a single dose.
  • Drug: BION-1301 Multiple Doses
    A solution for IV infusion administered as multiple doses.
  • Drug: Placebo Multiple Doses
    A solution by IV infusion administered as multiple doses.
Study Arms  ICMJE
  • Experimental: Part 1: BION-1301
    Up to 5 cohorts with single ascending doses of BION-1301 administered by intravenous (IV) infusion.
    Intervention: Drug: BION-1301 Single Dose
  • Placebo Comparator: Part 1: Placebo
    Subjects will receive a single dose of placebo administered by IV infusion.
    Intervention: Drug: Placebo Single Dose
  • Experimental: Part 2: BION-1301
    Up to 3 cohorts with multiple doses of BION-1301 administered by intravenous (IV) infusion.
    Intervention: Drug: BION-1301 Multiple Doses
  • Placebo Comparator: Part 2: Placebo
    Subjects will receive placebo by IV infusion.
    Intervention: Drug: Placebo Multiple Doses
  • Experimental: Part 3: BION-1301
    Subjects will receive multiple doses of BION-1301 at a dose to be determined by IV infusion.
    Intervention: Drug: BION-1301 Multiple Doses
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 8, 2019)
73
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Muna Albayaty, MBChB, FFPM muna.albayaty@parexel.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03945318
Other Study ID Numbers  ICMJE ADU-CL-19
2018-003360-31 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Aduro Biotech, Inc.
Study Sponsor  ICMJE Aduro Biotech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aduro Biotech, Inc.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP