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

NCT ID: NCT05561530

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-07
• Study Completion Date: 2023-06-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ALG-125755

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

Group Type: EXPERIMENTAL

ALG-125755

Intervention Type: DRUG

single or multiple doses of ALG-125755

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

single or multiple doses of placebo

Interventions

ALG-125755

single or multiple doses of ALG-125755

Intervention Type: DRUG

Placebo

single or multiple doses of placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Female subjects must have a negative serum pregnancy test at screening

2. Subjects must have a 12-lead electrocardiogram (ECG) that meets the protocol criteria

1. Male or female between 18 and 55 years of age, extremes included.

2. Subjects must have a body mass index (BMI) of 18.0 to 32.0 kg/m2, extremes included.

1. Subjects must be 18 to 70 years of age, inclusive of extremes.

2. Subjects may have a BMI of 18.0 to 35.0 kg/m2, extremes included.

3. 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

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 standard drinks/week for women and ≥21 standard drinks/week for men

6. Subjects with Hepatitis A, B, C, D, E or HIV-1/HIV-2 infection or acute infections such as SARS- CoV-2 infection

1. Unwilling to abstain from alcohol use for 48 hours prior to start of study through end of study follow up.

2. 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]

1. Subjects who are positive for anti-HBs antibodies.

2. 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).

3. History or current evidence of cirrhosis.

4. Subjects with liver fibrosis that is classified as Metavir Score ≥F3 liver disease

5. Subjects must have absence of signs of hepatocellular carcinoma

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aligos Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Sofia, , Bulgaria

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

Chisinau, , Moldova

New Zealand Clinical Research

Auckland, , New Zealand

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

Bucharest, , Romania

Countries

Bulgaria; Moldova; New Zealand; Romania

Other Identifiers

ALG-125755-501

Identifier Type: -

Identifier Source: org_study_id