Nebulised BromAc in Healthy Volunteers

• Status: Not yet recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mucpharm Pty Ltd
• Collaborators: Mobius Medical Pty Ltd.; St George Hospital, Australia

Criteria

Inclusion Criteria:

• Aged 18 to 70 years

• Received complete vaccination against COVID-19 over one week from trial commencement, able to adhere to Health guidelines surrounding attendance to a public hospital, and completion of any hospital questionnaires

• Are considered suitable for the trial based on ability to follow protocol and provide informed consent

• Are within a 10km radius of a study centre for ensuring adherence to trial procedures and follow up

Exclusion Criteria:

• Have been in contact with a known case of COVID-19 or advised to undertake self-isolation

• Have known allergy (anaphylaxis) or sensitivity to pineapples, papain, bromeliads, (fruit or plant) sulphur, eggs or Acetylcysteine that cannot be managed with steroids or antihistamine prophylaxis or any other serious unrelated allergy

• Have symptoms of COVID-19 such as cough or shortness of breath or evidence of pulmonary disease, other respiratory disease including asthma or chronic obstructive pulmonary disease

• Have a coagulation disorder of any kind or are on anticoagulant or anti-platelet therapy, history of nose bleeds or easy bruising

• ECOG >2

• Have any other serious comorbidities where inclusion in the trial will subject the patient to a higher risk of adverse events

• Pregnant women are excluded from this study because BromAc has unknown but a potential risk for adverse events in nursing infants secondary to treatment of the mother. Breastfeeding should be discontinued if the mother is treated with BromAc

• Patients with psychiatric illness/social situations that would limit compliance with study requirements

• Are unable to give fully informed and educated consent or are unable to comply with the standard follow up procedures of a clinical trial