ALG-097558 – first doses in humans

• Research type

  Research Study

• Full title

  A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

• IRAS ID

  1007517

• Contact name

  Jen Rito

• Contact email

  jrito@aligos.com

• Sponsor organisation

  Aligos Therapeutics, Inc.

• Research summary

  ALG-097558 is an experimental medicine for treating COVID-19, a viral infectious disease caused by the SARS-CoV-2 virus. Once the virus enters the body, it quickly replicates (makes copies of itself) inside cells, causing infection. We hope the study medicine will work by blocking a substance that the virus needs to replicate.
  This is a 6-part study in up to 144 healthy volunteers aged 18–55.
  We’ll give healthy volunteers single or repeated oral doses of ALG-097558 to find out:
  * The side effects of ALG-097558 when given alone or in combination with other medicines
  * How much of ALG-097558 gets into the bloodstream, and how the body gets rid of it
  * If ALG-097558 interacts with other medicines
  * If food affects the blood levels of ALG-097558 and to compare tablet and liquid forms
  * If ALG-097558 affects the results of an ECG (a test that records heart rhythms)
  Participants will take up to 6 weeks to finish the study and make up to 3 outpatient visits.
  In Part 1, up to 7 groups of 8 participants will take a single dose of ALG-097558 or placebo. They’ll have up to 2 study sessions and stay on the ward for 3 nights in a row per session. ALG-097558 has never been given to humans before so we’ll start with a small dose and increase the dose as the study progresses.
  In Part 2, up to 5 groups of 8 participants will take 2 daily doses of ALG-097558 or placebo for up to 10 days and stay on the ward for up to 12 nights in a row.
  In Parts 3–5, 12 participants will take a single or repeated dose of an existing medicine with single or repeated doses of ALG-097558 or placebo. They’ll stay on the ward for up to 20 nights.
  In Part 6, 12 participants will take 3 single doses of ALG-097558 as a liquid or tablet for 3 days. On one of those days they’ll take ALG-097558 after a fatty breakfast. Participants will stay on the ward for 9 nights in a row.
  A pharmaceutical company (Aligos Therapeutics, Inc) is funding the study.
  The study will take place at 1 centre in London

• REC name

  London - Brent Research Ethics Committee

• REC reference

  23/LO/0259

• Date of REC Opinion

  8 Jun 2023

• REC opinion

  Further Information Favourable Opinion