A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects

NCT05001022 | Terminated Phase 1

• 1 other identifier: ALG-020572-401
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 3

Brief Summary

A Randomized Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

  up to 60 days for Part 1

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1

  up to 120 days for Part 2

Secondary Outcomes (6)

• Maximum Plasma Concentration [Cmax]

  Predose (0 hours) up to 45 Days (1080 hours)

• Area under the concentration time curve [AUC]

  Predose (0 hours) up to 45 Days (1080 hours)

• Time to maximum plasma concentration [Tmax]

  Predose (0 hours) up to 45 Days (1080 hours)

• Half-time [t1/2]

  Predose (0 hours) up to 45 Days (1080 hours)

• Minimum Plasma Concentration [Cmin]

  Predose (0 hours) up to 45 Days (1080 hours)

Study Arms (2)

ALG-020572

EXPERIMENTAL

Subcutaneous injections of ALG-020572 in HV or CHB subjects, up to 7 injections over the course of up to 29 days

Drug: ALG-020572

Placebo

PLACEBO COMPARATOR

Subcutaneous injections of placebo in HV or CHB subjects, up to 7 injections over the course of up to 29 days

Drug: Placebo

Interventions

ALG-020572 DRUG

Single or multiple doses of ALG-020572

ALG-020572

Placebo DRUG

Single or multiple doses of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female between 18 and 55 years old
• Female subjects must have a negative serum pregnancy test at screening
• BMI 18.0 to 32.0 kg/m\^2
• Subjects must have a 12-lead ECG that meets protocol criteria
• Male and Female between 18 and 75 years old
• Female subjects must have a negative serum pregnancy test at screening
• BMI 18.0 to 35.0 kg/m\^2
• For virally suppressed subjects, must be currently receiving HBV NA treatment for ≥6 months prior to screening. For currently not treated or treatment naïve subjects, must have never received treatment OR have not been on treatment within 6 months prior to randomization
• Subjects must have a 12-lead ECG that meets protocol criteria

You may not qualify if:

• Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
• Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
• Subjects with a history of clinically significant drug allergy
• Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
• Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
• Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up
• Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
• Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)
• Subjects with any current or previous illness that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject or that could prevent, limit, or confound the protocol specified assessments or study results' interpretation
• Subjects with a past history of cardiac arrhythmias, risk factors for Torsade de Pointes syndrome (e.g., hypokalemia, family history of long QT Syndrome) or history or clinical evidence at screening of significant or unstable cardiac disease etc.
• Subjects with a history of clinically significant drug allergy
• Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
• Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
• Subjects with Hepatitis A, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
• Subjects with renal dysfunction (e.g., estimated creatinine clearance \<90 mL/min/1.73 m\^2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula)

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (3)

Auckland Clinical Studies

Auckland, New Zealand

Location

King's College Hospital

London, United Kingdom

Location

St George's University of London

London, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2021
• First Posted: August 11, 2021
• Study Start: September 25, 2021
• Primary Completion: July 18, 2022
• Study Completion: July 18, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

NZ (1); GB (2)