A Single and Multiple Ascending Dose Study of AGMB-447.
Research type
Research Study
Full title
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Inhaled AGMB-447 in Healthy Participants and Participants with Idiopathic Pulmonary Fibrosis
IRAS ID
1007789
Contact name
Tim Van Kaem
Contact email
Sponsor organisation
Agomab Spain S.L.
Research summary
The Sponsor, Agomab Spain S.L., is developing a new experimental study medication called AGMB-447, for the purpose of treating Idiopathic Pulmonary Fibrosis (IPF). Idiopathic Pulmonary Fibrosis (IPF) is a condition in which the lungs become scarred and breathing becomes increasingly difficult. The current treatments are supportive care, lung transplant or medicinal intervention. AGMB-447 is hoped to help patients who have been diagnosed with IPF by preventing lung scarring and breathing difficulties. The study medication will be inhaled (administered via a nebulizer, which gives the medication in a mist form over a few minutes), which helps to directly target its activity to the lungs. AGMB-447 is a lung-restricted ALK5 inhibitor which is anticipated to reduce TGF-b signalling in the lungs. TGF-b is a major regulator of fibrogenesis and fibrinolysis, and therefore AGMB-447 is anticipated . If the drug is safe and well tolerated, it may in the longer-term result in it being licensed and available on prescription for patients who have been diagnosed with IPF. This is the first study with AGMB-447 in humans and is designed to determine whether the study drug is safe and well tolerated in healthy participants and participants with IPF.
The study is split into for three parts:
- Part A will look at a single ascending doses of AGMB-447 (or placebo) in healthy participants.
- Part B will look at multiple ascending doses of AGMB-447 (or placebo) in healthy participants.
- Part C will look at multiple doses of AGMB-447 (or placebo) in participants with IPF.
A randomized, double-blind, placebo-controlled design has been selected to allow for unbiased analysis of safety and tolerability data. The study will be conducted in a dose escalation format in order to characterise doses that are anticipated to be safe and efficacious in the treatment of IPF. Dose escalation will be based on safety, tolerability, and available systemic PK data from previous cohorts.REC name
London - Brent Research Ethics Committee
REC reference
23/LO/0687
Date of REC Opinion
27 Nov 2023
REC opinion
Further Information Favourable Opinion