Modulate Cellular Stress in the Immune Cells to Reduce Rate of Symptomatic Viral Infection
Status:
Recruiting
Trial end date:
2023-01-01
Target enrollment:
Participant gender:
Summary
To address Aim 1, the investigators will conduct an open-label healthy volunteer study. The
study team will recruit 48 healthy adult subjects aged 21-40 years, with a Body Mass Index of
20-25 kg/m2, have no known drug allergies and are not currently receiving regular
immune-modulating therapy such as metformin, NSAIDs, paracetamol, corticosteroids or statins.
The age range that the investigators propose will ensure that the volunteers are likely to be
healthy and not be on long-term medication for other concurrent medical conditions. Informed
written consent will be obtained before any physical examination is performed. All consented
subjects will undergo health screening, which includes a full physical examination, safety
blood tests such as full blood count, renal, lipid and liver panel, C-Reactive Protein (CRP)
test and urinary pregnancy test (for female subjects of child-bearing potential), and HbA1c
to exclude diabetes mellitus. Eligible subjects will be randomized into 4 groups to receive
metformin 850mg or 1000mg once or twice daily for 10 days. Aim 1 tests the hypothesis that
metformin reduces ER stress in a dose-dependent manner. The primary objective of aim 1 is to
define the dose and kinetics of metformin in modulating ER stress in whole blood of healthy
adult volunteers.