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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04536337
Other study ID # ALG-000184-201
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date October 22, 2020
Est. completion date June 1, 2024

Study information

Verified date November 2022
Source Aligos Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Randomized Study of ALG-000184 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Doses in Healthy Volunteers and CHB Subjects


Recruitment information / eligibility

Status Recruiting
Enrollment 336
Est. completion date June 1, 2024
Est. primary completion date November 24, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria for All Subjects: 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 Inclusion Criteria for Healthy Volunteers: In addition to inclusion criteria 1-2, the following inclusion criteria also apply to HV's (Parts 1 and 2) 3. Male or female between 18 and 55 years of age, extremes included. 4. Subjects must have a body mass index (BMI; weight in kg divided by the square of height in meters) of 18.0 to 32.0 kg/m2, extremes included. CHB Subjects: In addition to inclusion criteria 1-4, the following inclusion criteria also apply to CHB subjects: All of the Following criteria apply to Part 3 at screening: 5 .Subjects must be 18 to 65 years of age, extremes included. 6.CHB subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included. 7.CHB subjects who at screening, have not received treatment with an approved or investigational medicine, or have never received treatment with HBV antiviral medicines All of the following criteria apply to Part 4 Cohorts A & B, unless otherwise specified, at Screening: 8.Subjects must be 18 to 65 years of age, extremes included. 9.Subjects must have a BMI of 18.0 to 35.0 kg/m2, extremes included 10.Subjects must be HBeAg positive (HBeAg =LLOQ and HBeAb negative) 11.Subjects enrolled in Part 4 Cohort A and B must have a history of Chronic Hepatitis B 12. Subjects must have ALT and AST must have =1.2×ULN or =5×ULN All of the following criteria apply to Part 5 at Screening 13.Subjects must be 18 to 65 years of age, extremes included. 14. Subjects have a BMI of 17.0 to 35.0 kg/m2, extremes included 15.Subjects could belong to any of the following treatment categories: treatment naïve (TN), currently not treated (CNT) , virologically suppressed. Exclusion Criteria Exclusion Criteria for All Subjects: 1. Subjects with any previous or current 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 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 of clinical evidence at screening of significant or unstable cardiac disease etc. 3. Subjects with a history of clinically significant drug allergy 4. Subject with a current history of clinically significant (as determined by 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 Exclusion Criteria for Healthy Volunteers (Parts 1 and 2): In addition to exclusion criteria 1-6, the following exclusion criteria also apply to HV's (Parts 1 and 2) 7. Unwilling to abstain from alcohol use for 48 hours prior to start of dosing through end of study follow up. 8. Positive alcohol or cotinine test at screening and Day -1. 9. Subjects with renal dysfunction (e.g., estimated creatinine clearance <90 mL/min/1.73 m2at screening, calculated by the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula). Exclusion Criteria for CHB Subjects (Parts 3, 4, and 5): All exclusion criteria listed above for healthy volunteers apply also to CHB subjects, except for exclusion Criteria 9 (requirement relative to cotinine).All the following exclusion criteria apply to Parts 3, 4, and 5, unless otherwise specified. 10. Subjects who are positive for anti-HBs antibodies. 11. For HBeAg-positive subjects, they should be negative for anti-HBe antibodies (Parts 4 and 5) 12. 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). 13. History or current evidence of cirrhosis. 14. Subjects with liver fibrosis that is classified as Metavir Score =F3 liver disease 15. Subjects with signs of hepatocellular carcinoma

Study Design


Intervention

Drug:
ALG-000184
Single or multiple doses of ALG-000184
Placebo
Single or multiple doses of Placebo
Entecavir
multiple doses of Entecavir

Locations

Country Name City State
Australia Saint Vincent's Hospital Melbourne Fitzroy Victoria
Australia Western Health Footscray Victoria
China The First Hospital of Jilin University Changchun Jilin
China The Second Affiliated Hospital of Chongqing Medical University Chongqing Chongqing
China Nanfang Hospital of Southern Medical University Guangzhou Guangdong
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Prince of Wales Shatin
Mauritius CAP Research Quatre Bornes
Moldova, Republic of PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit Chisinau
New Zealand ACS Auckland
United Kingdom King's College Hospital London
United Kingdom St George's University of London London

Sponsors (1)

Lead Sponsor Collaborator
Aligos Therapeutics

Countries where clinical trial is conducted

Australia,  China,  Hong Kong,  Mauritius,  Moldova, Republic of,  New Zealand,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 8 days for Part 1
Primary 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 21 days for Part 2
Primary 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 112 days for Part 3
Primary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] The number and severity of treatment emergent adverse events as assessed by DAIDS v2.1 of ALG-184 in combination with Entecavir (Parts 4 and 5) Up to 336 days for parts 4 & 5
Secondary Maximum Plasma Concentration [Cmax] Pharmacokinetic parameters of ALG-000184 in plasma Predose up to 343 Days
Secondary Area under the concentration time curve [AUC] Pharmacokinetic parameters of ALG-000184 in plasma Predose up to 343 Days
Secondary Time to maximum plasma concentration [Tmax] pharmacokinetic parameters of ALG-000184 in plasma Predose up to 343 Days
Secondary Half-time [t1/2] Pharmacokinetic parameters of ALG-000184 in plasma Predose up to 343 Days
Secondary Minimum Plasma Concentration [Cmin] Pharmacokinetic parameters of ALG-000184 in plasma Predose up to 343 Days
Secondary Change in HBV DNA from baseline through Day 392 in Multiple Dose HBV Infected Patients Screening up to Day 392
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