Aligos AL020572-401 CTA Application

• Research type

  Research Study

• Full title

  A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-020572 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Multiple Doses in Subjects with Chronic Hepatitis B (Part 2)

• IRAS ID

  1004256

• Contact name

  Luther Sampson

• Contact email

  luther.sampson@dlrc.co.uk

• Sponsor organisation

  Aligos Therapeutics, Inc

• Eudract number

  2021-003904-42

• Clinicaltrials.gov Identifier

  NCT05001022

• Research summary

  Chronic Hepatitis B (CHB) infection is a global public health problem with significant morbidity and mortality. The
  study drug, ALG-020572, is being developed as a potential new treatment for CHB infection. This is the first time
  that ALG-020572 will be administered to humans. The study aims to investigate whether ALG-020572 is safe and
  well tolerated when given at different doses, and will also measure the levels of the drug in the blood at different
  times.
  The study is comprised of two parts: Part 1, and Part 2.
  Part 1 will consist of up to 64 healthy participants, enrolled in up to 8 different cohorts, including two optional cohorts
  (cohorts 7 & 8). Each cohort will be comprised of 8 participants who will receive a single dose of ALG-020572 or
  placebo in a 3:1 ratio (ALG-020572:placebo), administered subcutaneously (SC). The starting dose in cohort 1 will
  be 50mg, and subsequent doses will be determined based on the safety and tolerability of the preceding data.
  Within each Part 1 cohort, at least 4 Asian participants (50%) will be enrolled in order to evaluate the potential effect
  of ethnicity on drug metabolism.
  Part 2 will consist of up to 48 CHB patients, approx. 24 patients who are Hepatitis B e-antigen (HBeAg) negative and
  24 patients who are HBeAg positive. Patients that are HBeAg negative will enrol into cohort 1, 2 or 3 and patients
  that are HBeAg positive or negative will enrol into cohort 4, 5 or 6. Patients will be randomised to receive 7 doses of
  ALG-020572 or placebo in a 3:1 ratio (ALG-020572:placebo) via SC injection. The Part 2 doses will be confirmed
  following analysis of the data from Part 1, and ongoing data from Part 2.

• REC name

  North East - York Research Ethics Committee

• REC reference

  21/NE/0203

• Date of REC Opinion

  14 Dec 2021

• REC opinion

  Favourable Opinion