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TERMINATEDPHASE1

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

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)

NCT05001022•Aligos Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male and Female between 18 and 55 years old
•2. Female subjects must have a negative serum pregnancy test at screening
•3. BMI 18.0 to 32.0 kg/m\^2
•4. Subjects must have a 12-lead ECG that meets protocol criteria
•1. Male and Female between 18 and 75 years old
•2. Female subjects must have a negative serum pregnancy test at screening
•3. BMI 18.0 to 35.0 kg/m\^2
•4. 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
•5. Subjects must have a 12-lead ECG that meets protocol criteria

Exclusion Criteria

•1. 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
•2. 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.
•3. Subjects with a history of clinically significant drug allergy
•4. Subject with current or history of clinically significant (as determined by the Investigator) skin disease requiring intermittent or chronic treatment
•5. Excessive use of alcohol defined as regular consumption of ≥14 units/week for women and ≥21 units/week for men
•6. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up
•7. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
•8. 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)
•1. 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
•2. 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.
+10 more criteria

Locations (3)

Auckland Clinical Studies

Auckland, New Zealand

King's College Hospital

London, United Kingdom

St George's University of London

London, United Kingdom

Key Dates

Start Date

September 25, 2021

Primary Completion Date

July 18, 2022

Completion Date

July 18, 2022

Last Updated

April 25, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Hepatitis B

Interventions

ALG-020572

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 25, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients

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