A Study of ALG-010133 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects

NCT04485663 | Terminated Phase 1

• 1 other identifier: ALG-010133-101
• Study Type: interventional
• Target: 103
• Locations: 6 countries
• Sites: 10

Brief Summary

A Randomized Study of ALG-010133 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 (3)

• 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 15 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 29 days for Part 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 162 days for Part 3

Secondary Outcomes (6)

• Maximum Plasma Concentration [Cmax]

  Predose (0 hours) up to 162 Days (3864 hours)

• Area under the concentration time curve [AUC]

  Predose (0 hours) up to 162 Days (3864 hours)

• Time to maximum plasma concentration [Tmax]

  Predose (0 hours) up to 162 Days (3864 hours)

• Half-time [t1/2]

  Predose (0 hours) up to 162 Days (3864 hours)

• Minimum Plasma Concentration [Cmin]

  Predose (0 hours) up to 162 Days (3864 hours)

Study Arms (2)

ALG-010133

EXPERIMENTAL

Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks

Drug: ALG-010133

Placebo

PLACEBO COMPARATOR

Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks

Drug: Placebo

Interventions

ALG-010133 DRUG

Single or multiple doses of ALG-010133

ALG-010133

Placebo DRUG

Single or multiple doses of Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 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
• Subjects must be nonsmokers for at least 3 months prior to randomization
• 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 70 years old
• Female subjects must have a negative serum pregnancy test at screening
• BMI 18.0 to 35.0 kg/m\^2
• HBeAg-negative chronic hepatitis B or HBeAg-positive chronic hepatitis B and are currently receiving HBV NA treatment for ≥6 months prior to screening
• 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 (10)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Queen Mary Hospital

Hong Kong, Hong Kong

Location

PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit

Chisinau, Moldova

Location

ACS

Auckland, New Zealand

Location

Pusan National University Hospital

Busan, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

King's College Hospital

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: July 9, 2020
• First Posted: July 24, 2020
• Study Start: August 17, 2020
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: March 15, 2022

Record last verified: 2022-03

Locations

NZ (1); MO (1); KR (4); GB (1); CN (2); HK (1)