History of Changes for Study: NCT03945318

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

Latest version (submitted April 18, 2024) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	May 8, 2019	None (earliest Version on record)
2	February 24, 2020	Recruitment Status, Study Status, Contacts/Locations, Eligibility, Oversight, Outcome Measures, Arms and Interventions, Study Design and Study Description
3	April 24, 2020	Recruitment Status, Study Status and Contacts/Locations
4	May 21, 2020	Study Status and Contacts/Locations
5	June 12, 2020	Study Status and Contacts/Locations
6	July 8, 2020	Study Status and Contacts/Locations
7	September 14, 2020	Study Status and Contacts/Locations
8	September 21, 2020	Contacts/Locations and Study Status
9	October 12, 2020	Contacts/Locations and Study Status
10	December 21, 2020	Study Status, Sponsor/Collaborators, Study Identification, Contacts/Locations and Eligibility
11	May 6, 2021	Study Status and Contacts/Locations
12	December 9, 2021	Contacts/Locations, Study Status, Arms and Interventions, Study Design, Eligibility, Outcome Measures, Study Description and Study Identification
13	January 28, 2022	Study Status and Contacts/Locations
14	June 6, 2022	Contacts/Locations, Study Status and Eligibility
15	January 9, 2023	Recruitment Status, Contacts/Locations, Study Status, Study Design and Arms and Interventions
16	May 23, 2023	Study Status, Contacts/Locations, Arms and Interventions and Study Description
17	November 1, 2023	Study Status, Arms and Interventions, Contacts/Locations, Study Design, Eligibility, Outcome Measures and Study Description
18	January 23, 2024	Contacts/Locations and Study Status
19	April 9, 2024	Study Status
20	April 18, 2024	Contacts/Locations and Study Status

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Study NCT03945318
Submitted Date: May 8, 2019 (v1)

Study Identification


Unique Protocol ID:	ADU-CL-19
Brief Title:	Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)
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
Secondary IDs:	2018-003360-31 [EudraCT Number]

Study Status


Record Verification:	May 2019
Overall Status:	Recruiting
Study Start:	April 8, 2019
Primary Completion:	November 2020 [Anticipated]
Study Completion:	November 2020 [Anticipated]

First Submitted:	April 21, 2019
First Submitted that Met QC Criteria:	May 8, 2019
First Posted:	May 10, 2019 [Actual]

Last Update Submitted that Met QC Criteria:	May 8, 2019
Last Update Posted:	May 10, 2019 [Actual]

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).

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 Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 1
Interventional Study Model:	Parallel Assignment
	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.
Number of Arms:	5
Masking:	Triple (Participant, Care Provider, Investigator)
Allocation:	Randomized
Enrollment:	73 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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.

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 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. ]

Eligibility


Minimum Age:	18 Years
Maximum Age:	55 Years
Sex:	All
Gender Based:
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

Contacts/Locations


Central Contact Person:	Muna Albayaty, MBChB, FFPM Email: muna.albayaty@parexel.com
Locations:	United Kingdom
	PAREXEL Early Phase Clinical Unit [Recruiting] London, United Kingdom, HA1 3UJ Contact:Contact: Muna Albayaty, MBChB, FFPM muna.albayaty@parexel.com

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