ALG-000184-201
Research type
Research Study
Full title
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Orally Administered ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single-Ascending Doses (Part 1) and Multiple-Ascending Doses in Healthy Volunteers (Part 2), and Multiple Doses in Subjects with Chronic Hepatitis B (Part 3)
IRAS ID
289837
Contact name
Kaushik Agarwal
Contact email
Sponsor organisation
Aligos Therapeutics Inc.
Eudract number
2020-004037-20
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
ALG-000184 is a novel drug which belongs to a group of small molecule antivirals known as Capsid assembly modulators (CAMs). In assays using human liver cells (HepG2.2.15 or HepG2-117), ALG-000184 has demonstrated highly potent inhibition of viral replication indicating rapid hydrolysis to the parent molecule.
ALG-000184 is a global, multicentre, phase I, randomized, double-blind, placebo-controlled study which will evaluate the safety, tolerability, pharmacokinetics and Pharmacodynamics of ALG-000184 after 'Single-Ascending Doses (Part 1), and Multiple-Ascending doses in healthy volunteers (Part 2) and Multiple-Ascending doses in subjects with chronic hepatitis B (Part 3). The study will be conducted in 3 Parts. In the UK, only a single site will conduct part 3 of the study.
Up to 60 hepatitis B e-antigen (HBeAg) negative subjects will be included in part 3 of the study globally. The aim of this part is to investigate the safety, tolerability, PK, and antiviral activity of 28 daily oral doses of ALG-000184. The initial dose will be selected based on the Dose Selection Guidelines.
Four cohorts (Cohorts 1 to 4) of 10 subjects each (40 subjects in total) and up to two optional cohorts (Cohorts 5 and 6) of 10 subjects each (20 subjects in total), will receive 28 oral doses of ALG-000184 or matching placebo administered once daily over 4 weeks in a fasted or fed state (based on data from Part 1). Within each cohort, 8 subjects will be randomly assigned to receive ALG-000184 and 2 subjects will receive matching placebo.
A Safety Review Committee (SRC) will conduct Data Review Meetings (DRM) to review the available safety data in order to decide upon dose escalation and cohort progression.
A separate ALT Flare Committee will review emerging ALT events of interest as defined in the protocol.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/1290
Date of REC Opinion
25 Jan 2021
REC opinion
Further Information Favourable Opinion