Nebulised BromAc in Healthy Volunteers

Summary

COVID-19 is a disease that has multiple facets including an inflammatory storm, it promotes blood clotting and causes kidney damage, mucinous secretions in the lung are of great importance to outcome. Increasingly sticky sputum is associated with critical illness, with considerably raised levels of a specific type of mucous protein (MUC5AC) in sputum in COVID-19 patients. There is a strong link between viral infection and mucus production via multiple inter-cellular signalling pathways including Interleukin (IL)6, IL10 and Tumour Necrosis Factor (TNF) whereby the inflammatory storm causes sudden secretion of high volumes of dense mucus.

An Australian pharmaceutical company has developed BromAc (Bromelain \& Acetylcysteine) for the palliative treatment of highly mucinous tumors of the appendix and lung. During pre-clinical development, they found that BromAc® rapidly dissolved and removed tumour mucin, making it a potent mucolytic. In combination, bromelain and acetylcysteine disrupt the architecture of the SARS-COV-2 virus in a way that renders it non-infective, reduced cytokines and chemokines in COVID-19 sputum and is a highly effective respiratory mucolytic.

The aim of this study is to assess whether BromAc delivered into the respiratory tract as a nebulised aerosol is tolerated and safe at three specific concentrations in healthy volunteer participants. The investigators will further assess the safety of nebulised BromAc and efficacy of the drug product as a mucolytic and anti-inflammatory, and whether this improves clinical outcome in participants with COVID-19. The hypothesis is that BromAc will be tolerated by patients and will result in mucus clearance, improving oxygenation and compliance in those that are ventilated.

This is a phase I study on the safety of BromAc, where 12 healthy volunteers will receive BromAc as a nebulised aerosol into the respiratory tract. BromAc is a product that combines two existing products to be delivered into the respiratory tract via nebulised aerosol delivery through a mask. The participant will be assessed for symptoms and side effects. The participant will receive nebulised BromAc at the allocated dose level for a total of 3 days. The hypothesis is that nebulised airway delivery of BromAc will be safe at the concentrations assessed.

Conditions

• COVID-19 Pneumonia
• Bromelains Adverse Reaction
• Acetylcysteine Adverse Reaction
• Mucus; Plug
• COVID-19 Acute Respiratory Distress Syndrome

Interventions

DRUG

BromAc

Bromelain and acetylcysteine are combined in various concentrations (either 100ug, 150ug or 200ug of bromelain, with 20mg of acetylcysteine). This is then delivered by a nebuliser to up to 12 healthy volunteers. The primary aim is determining safety.

Sponsors & Collaborators

• St George Hospital, Australia

  collaborator OTHER

• Mobius Medical Pty Ltd.

  collaborator INDUSTRY

• Mucpharm Pty Ltd

  lead INDUSTRY

Principal Investigators

• Frank van Haren, MD, PhD · St George Hospital, Director of Intensive Care

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-07-27

Primary Completion

2022-08-14

Completion

2022-08-25

FDA Drug

Yes

Countries

• Australia

Study Locations