ALG-000184 for Chronic hepatitis B

Inclusion criteria

• {"criterion_text":"- Male or female between 18 and 65 years of age, with body mass index (BMI) of 18.0 to 35.0 kg/m2.\n- HBeAg-positive and anti-HBeAg (HBeAb) negative (Part 1); or HBeAg-negative (Part 2).\n- HBsAg ≥ LLOQ\n- HBV DNA ≥20,000 IU/mL.\n- A history of a clinical diagnosis of chronic HBV infection AND a serum ALT values of ≤8×ULN during screening.\n- Must have the following chronic hepatitis B virus infection treatment status at screening: a. Have never received treatment with HBV antiviral medicines (NA, interferon) or investigational anti-HBV agents including a CAM [i.e., Treatment Naïve (TN) subjects], OR b. Have not been on treatment with approved (NA, interferon) or investigational HBV antiviral medicines (e.g., antisense oligonucleotides or small interfering RNAs) within 6 months or 5 half-lives (whichever is longer) prior to randomization (i.e., Currently Not Treated (CNT) subjects)."}

Exclusion criteria

• {"criterion_text":"- Co-infection with hepatitis A, C, D, E or HIV or any evidence of clinically significant liver disease of non-HBV etiology.\n- Positive for anti-HBs antibodies.\n- History or current evidence of cirrhosis.\n- Liver fibrosis that is classified as Metavir Score ≥F3 liver disease.\n- History of, or current evidence of, hepatic decompensation.\n- Evidence of hepatocellular carcinoma (HCC) on a liver ultrasound.\n- Having received an investigational medicinal product or device within 4 weeks (or 5 half-lives, whichever is longer) before the planned first dose of study drug\n- Exclusionary screening laboratory values include: a. Aspartate aminotransferase (AST) >8×ULN, b. Bilirubin (total, direct) >1.2×ULN (unless Gilbert's syndrome is suspected) c. International Normalization Ratio (INR) >1.2×ULN"}

Primary endpoints

• {"endpoint_text":"- Part 1 (HBeAg positive): Plasma HBV DNA < LLOQ (10 IU/mL, TD [target detected] or target not detected [TND])at Week 48","definition_or_measurement_approach":"Plasma HBV DNA measured with LLOQ = 10 IU/mL; responder defined as HBV DNA < LLOQ (either TD or TND) at Week 48 (Part 1)."}
• {"endpoint_text":"- Part 2 (HBeAg negative): Plasma HBV DNA < LLOQ (10 IU/mL, TND) at Week 48","definition_or_measurement_approach":"Plasma HBV DNA measured with LLOQ = 10 IU/mL; responder defined as HBV DNA < LLOQ with target not detected (TND) at Week 48 (Part 2)."}

Secondary endpoints

• {"endpoint_text":"- Safety will be assessed by monitoring treatment-emergent adverse events, physical examinations, vital signs, 12-lead electrocardiograms (ECGs), and clinical laboratory results (including chemistry, blood coagulation, hematology, and urinalysis).","definition_or_measurement_approach":"Safety assessed by recording TEAEs, physical exams, vital signs, 12-lead ECGs, and clinical labs (chemistry, coagulation, hematology, urinalysis)."}
• {"endpoint_text":"- Plasma HBV DNA level at Week 48 categorized according to one of the following ordinal categories: HBV DNA ≥ LLOQ, HBV DNA < LLOQ (TD), and HBV DNA < LLOQ (TND)","definition_or_measurement_approach":"Plasma HBV DNA measured at Week 48 and categorized into ≥LLOQ, <LLOQ (TD) or <LLOQ (TND)."}
• {"endpoint_text":"- Plasma HBV DNA < LLOQ (TD or TND) at various time points during the 48-week dosing period (Part 1 only)","definition_or_measurement_approach":"Serial plasma HBV DNA measurements during dosing period; assessment of <LLOQ (TD or TND) at prespecified timepoints (Part 1)."}
• {"endpoint_text":"- Plasma HBV DNA < LLOQ (TND) at various time points during the 48-week dosing period (Part 2 only)","definition_or_measurement_approach":"Serial plasma HBV DNA measurements during dosing period; assessment of <LLOQ with TND at prespecified timepoints (Part 2)."}
• {"endpoint_text":"- Change from baseline in plasma HBV DNA at various time points during the 48-week dosing period","definition_or_measurement_approach":"Change from baseline in plasma HBV DNA measured at multiple time points during 48-week dosing period."}
• {"endpoint_text":"- Time to plasma HBV DNA < LLOQ (TD or TND) (Part 1 only)","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomization to first plasma HBV DNA < LLOQ (TD or TND) in Part 1."}
• {"endpoint_text":"- Time to plasma HBV DNA < LLOQ (TND) (Part 2 only)","definition_or_measurement_approach":"Time-to-event analysis measuring time from randomization to first plasma HBV DNA < LLOQ with TND in Part 2."}
• {"endpoint_text":"- Serum HBV RNA < LLOQ at various time points during the 48-week dosing period","definition_or_measurement_approach":"Serum HBV RNA measured at prespecified time points; proportion below LLOQ assessed."}
• {"endpoint_text":"- Change from baseline in serum HBV RNA at various time points during the 48-week dosing period","definition_or_measurement_approach":"Change from baseline in serum HBV RNA measured at multiple time points during 48-week dosing period."}
• {"endpoint_text":"- Time to serum HBV RNA < LLOQ","definition_or_measurement_approach":"Time-to-event analysis for time from randomization to serum HBV RNA < LLOQ."}
• {"endpoint_text":"- Subjects with abnormal ALT at baseline who have normal ALT at Week 48","definition_or_measurement_approach":"Proportion of subjects with abnormal baseline ALT who achieve normal ALT at Week 48 (ULN defined: 29 U/L in males and 18 U/L in females)."}
• {"endpoint_text":"- Emergence of treatment-associated mutations in the HBV genome during the 48-week dosing period and the 48- to 96-week dosing period","definition_or_measurement_approach":"Genotypic sequencing of HBV to detect treatment-associated mutations during specified periods (48 and 48–96 weeks)."}
• {"endpoint_text":"- PK parameters of ALG-001075 in plasma, including, but not limited to: Ctrough (predose), Tmax, Cmax, AUCss, and half-life, as applicable.","definition_or_measurement_approach":"Measurement of plasma PK parameters (Ctrough, Tmax, Cmax, AUCss, half-life) for ALG-001075 where applicable."}

Methods

• Country-specific recruitment arrangements documents and patient-facing materials: patient brochures and patient flyers (documents present for BG, ES, FR, RO, IT).
• Physician referral letters and study factsheets (France specific materials listed).
• Recruitment and informed consent procedure documents (country-specific K1 documents listed for BG, ES, FR, RO, IT).
• Patient information brochures / Patient Alert Cards (country-specific).

Bulgaria

Earliest CTIS Part Ii Submission Date

12-08-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

48

Number Of Sites

4

Number Of Participants

10

Spain

Earliest CTIS Part Ii Submission Date

26-08-2025

Latest Decision Or Authorization Date

24-09-2025

Processing Time Days

29

Number Of Sites

3

Number Of Participants

10

France

Earliest CTIS Part Ii Submission Date

25-08-2025

Latest Decision Or Authorization Date

26-09-2025

Processing Time Days

32

Number Of Sites

6

Number Of Participants

10

Romania

Earliest CTIS Part Ii Submission Date

23-06-2025

Latest Decision Or Authorization Date

29-09-2025

Processing Time Days

98

Number Of Sites

2

Number Of Participants

10

Italy

Earliest CTIS Part Ii Submission Date

18-07-2025

Latest Decision Or Authorization Date

25-09-2025

Processing Time Days

69

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

Aligos Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Fortrea Inc.

Responsibilities

Operational study responsibilities (multiple sponsorDuties codes listed)

Name

Syneos Health Inc.

Responsibilities

PK Plasma samples

Name

Ppd Inc.

Responsibilities

Global Pharmacovigilance

Third parties

• {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"Backup PK Plasma samples","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"ClinStatDevice LLC","duties_or_roles":"","organisation_type":"Industry"}
• {"country":"Japan","full_name":"Fujirebio (SRL) Inc Central Laboratory","duties_or_roles":"HBcrAg (eAg-ve)","organisation_type":"Industry"}
• {"country":"Hong Kong","full_name":"KingmyLab Pharmaceuticals","duties_or_roles":"HBeAg and Hbe Ab (quantitative)","organisation_type":"Industry"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Multiple operational and study responsibilities (codes present in CTIS sponsorDuties array)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"Treatment Randomisation","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"PK Plasma samples","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"VIDRL","duties_or_roles":"HBV genome sequencing","organisation_type":"Health care"}
• {"country":"United States","full_name":"Ppd Inc.","duties_or_roles":"Global Pharmacovigilance","organisation_type":"Pharmaceutical company"}