A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects

NCT05561530 | Terminated Phase 1

• 1 other identifier: ALG-125755-501
• Study Type: interventional
• Target: 57
• Locations: 4 countries
• Sites: 4

Brief Summary

A randomized study of ALG-125755 to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics after single doses in healthy volunteers, and single and multiple doses in CHB subjects

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (3)

• Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of various doses of ALG-125755 in HV subjects and CHB subjects

  Up to 32 days for Part 1

• Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1

  Up to 52 days for Part 2

• Incidence and severity of treatment emergent adverse events as assessed by DAIDS v2.1

  Up to 616 days for Part 3

Secondary Outcomes (6)

• Maximum plasma concentration (Cmax)

  Predose (0 hours) up to 616 days

• Area under the concentration time curve [AUC]

  Predose (0 hours) up to 616 days

• Time to maximum plasma concentration [Tmax]

  Predose (0 hours) up to 616 days

• Antiviral activity of ALG-125755 as measured by quantitative changes in serum

  Predose (0 hours) up to 616 days

• Minimum plasma concentration (Cmin)

  Predose (0 hours) up to 616 days

Study Arms (2)

ALG-125755

EXPERIMENTAL

Subcutaneous injections of ALG-125755 in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks

Drug: ALG-125755

Placebo

PLACEBO COMPARATOR

Subcutaneous injections of placebo in HV or CHB subjects, up to 6 injections over the course of up to 72 weeks

Drug: Placebo

Interventions

ALG-125755 DRUG

single or multiple doses of ALG-125755

ALG-125755

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:

• Female subjects must have a negative serum pregnancy test at screening
• Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria
• Male or female between 18 and 55 years of age, extremes included.
• Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.
• Subjects must be 18 to 70 years of age, inclusive of extremes.
• Subjects may have a BMI of 18.0 to 35.0 kg/m2, extremes included.
• 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

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 standard drinks/week for women and ≥21 standard drinks/week for men
• Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection
• Unwilling to abstain from alcohol use for 48 hours prior to start of study through end of study follow up.
• Subjects with renal dysfunction \[e.g., estimated creatinine clearance \<90 mL/min/1.73 m2 at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula\]
• Subjects who are positive for anti-HBs antibodies.
• Subject with any history or current evidence of hepatic decompensation such as: variceal bleeding, spontaneous bacterial peritonitis, ascites, hepatic encephalopathy, or active jaundice (within the last year).
• History or current evidence of cirrhosis.
• Subjects with liver fibrosis that is classified as Metavir Score ≥F3 liver disease
• Subjects must have absence of signs of hepatocellular carcinoma

Sponsors & Collaborators

• Aligos Therapeutics: lead

Study Sites (4)

MBAL Sveta Sofia EOOD, Dept of Internal Medicine with Gastroenterology Section

Sofia, Bulgaria

Location

PMSI Republican Clinical Hospital "t. Mosneaga", ARENSIA Exploratory Medicine Phase 1 Unit

Chisinau, Moldova

Location

New Zealand Clinical Research

Auckland, New Zealand

Location

National Institute for Infection Diseases, ARENSIA Exploratory Medicine S.R.L.

Bucharest, Romania

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: September 26, 2022
• First Posted: September 30, 2022
• Study Start: October 7, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

NZ (1); BU (1); MO (1); RO (1)