Phase1/2A to evaluate the effects of ARO-MMP7 in healthy subject and patients with IPF
Research type
Research Study
Full title
A PHASE 1/2A STUDY EVALUATING THE EFFECTS OF ARO-MMP7 INHALATION SOLUTION IN HEALTHY SUBJECTS AND PATIENTS WITH IDIOPATHIC PULMONARY FIBROSIS
IRAS ID
1008087
Contact name
Jesse Ho
Contact email
Sponsor organisation
Arrowhead Pharmaceuticals, Inc.
Eudract number
2023-504964-41
Clinicaltrials.gov Identifier
Research summary
This is a Phase 1/2a, randomized, double-blind, placebo-controlled study in NHVs and patients with IPF. ARO-MMP7 is intended for use in patients with IPF. However, because these patients may have baseline decreased lung function and are frequently on multiple concomitant medications, this study will first evaluate dose levels in an NHV population to generate a baseline understanding of safety in a population with normal airway physiology and limited concomitant medication use prior to evaluating dose levels in patients with IPF. Additionally, NHV cohorts will generate an initial understanding of dose-response, using MMP7 protein concentration as a biomarker of PD effect. For all cohorts, participants who have signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved informed consent form and met all the protocol eligibility criteria during Screening will be randomized to receive ARO-MMP7 or placebo.
The NHV population (different cohorts) described in the Protocol will take part in Countries out of Europe (New Zealand) and just the cohorts referring to patients with IPF, described in the Protocol, will take part in the European portion of the trial including UK.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
23/EE/0160
Date of REC Opinion
20 Oct 2023
REC opinion
Further Information Favourable Opinion