ALG-010133-101

• Research type

  Research Study

• Full title

  A Phase 1, Double-blind, Randomized, Placebo-controlled, First-inhuman Study of Subcutaneously Administered ALG-010133 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

  292035

• Contact name

  Kaushik Agarwal

• Contact email

  Kosh.agarwal@klc.ac.uk

• Sponsor organisation

  Aligos Therapeutics, Inc.

• Eudract number

  2020-002989-13

• Clinicaltrials.gov Identifier

  NCT04485663

• Duration of Study in the UK

  1 years, 0 months, 0 days

• Research summary

  ALG-010133, developed by Aligos Therapeutics, Inc, is an oligonucleotide S-antigen transport inhibiting oligonucleotide polymer (STOPS™) which interacts with specific proteins to decrease viral HBsAg levels, enabling functional cure in chronic hepatitis B. This is a phase 1, double-blind, randomized, placebo-controlled, first-in-human study of subcutaneously administered ALG-010133 to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics after single doses in healthy volunteers and multiple doses in subjects with chronic hepatitis B.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  21/LO/0227

• Date of REC Opinion

  19 Apr 2021

• REC opinion

  Further Information Favourable Opinion