Safety, Tolerabiliy. PK & PD study of BION-1301 in HV & IgAN patients
Research type
Research Study
Full 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
IRAS ID
254794
Contact name
Jonathan Barratt
Contact email
Sponsor organisation
Aduro Biotech, Inc.
Eudract number
2018-003360-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 7 months, 21 days
Research summary
This is a Phase I, multicentre study in healthy male and female volunteers and patients with IgA nephropathy (IgAN). The main purpose of the study is to see how safe the study drug, BION-1301, is and how well the body tolerates the study drug after single and repeated doses, administered intravenously. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) (overall referred to as pharmacokinetics [PK]). In addition, the study will investigate the effects of the study drug on the body (referred to as pharmacodynamics [PD]) and will explore the impact of the study drug on kidney function in the IgAN patients.
The study comprises three parts. In Part 1, single rising doses and in Part 2, repeated doses will be administered to healthy volunteers in a double-blind, randomised, placebo-controlled study design and in Part 3 an open-label repeated dose cohort of IgAN patients. Each study part includes a screening visit, treatment period, follow-up period and end-of-study visit. Eligible participants in Part 1 and 2 will stay in for approximately 48 hours after dosing. Female participants in Part 1 and 2 must be of non-childbearing potential.
This is not a first-in-human (FIH) study. The ongoing FIH study showed the study drug was generally well tolerated. To date, 11 patients with multiple myeloma have received at least one dose of BION-1301.
The study drug is being developed by Aduro Biotech Inc, for treatment of IgAN, a kidney disorder which results from the formation of auto-antibodies that cause inflammation and kidney damage. Current standard of care therapy for IgAN patients is blood pressure control. But, despite this treatment, patients may suffer persistent loss of blood proteins through their kidneys that leads to dialysis and kidney transplant. There is no effective therapy available to stop loss of blood proteins. Development of BION-1301 aims to address this unmet medical need for IgAN patients who do not benefit from blood pressure control alone.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
19/SC/0049
Date of REC Opinion
25 Mar 2019
REC opinion
Further Information Favourable Opinion