Not provided
Not provided
Not provided
Not provided
Not provided
Lack of antiviral activity at the projected efficacious dose.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALG-010133 | Experimental | Subcutaneous injections of ALG-010133 in HV or CHB subjects up to every 7 days for up to 12 weeks |
|
| Placebo | Placebo Comparator | Subcutaneous injections of placebo in HV or CHB subjects up to every 7 days for up to 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALG-010133 | Drug | Single or multiple doses of ALG-010133 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration [Cmax] | Pharmacokinetic parameters of ALG-010133 in plasma | Predose (0 hours) up to 162 Days (3864 hours) |
| Area under the concentration time curve [AUC] | Pharmacokinetic parameters of ALG-010133 in plasma |
Not provided
Inclusion Criteria for Healthy Subjects:
Inclusion Criteria for CHB Subjects:
Exclusion Criteria for Healthy Subjects:
Exclusion Criteria for CHB Subjects:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Southern Medical University | Guangzhou | Guangdong | China | |||
| The First Hospital of Jilin University |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Single or multiple doses of Placebo |
|
| Predose (0 hours) up to 162 Days (3864 hours) |
| Time to maximum plasma concentration [Tmax] | Pharmacokinetic parameters of ALG-010133 in plasma | Predose (0 hours) up to 162 Days (3864 hours) |
| Half-time [t1/2] | Pharmacokinetic parameters of ALG-010133 in plasma | Predose (0 hours) up to 162 Days (3864 hours) |
| Minimum Plasma Concentration [Cmin] | Pharmacokinetic parameters of ALG-010133 in plasma | Predose (0 hours) up to 162 Days (3864 hours) |
| Change in HBsAg (reduction) from baseline through Day 78 in Multiple Dose HBV Infected Patients | Screening, Day -1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78 |
| Changchun |
| Jilin |
| 130021 |
| China |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| PMSI Republican Clinical Hospital "T. Mosneaga", ARENSIA Exploratory Medicine Phase I Unit | Chisinau | Moldova |
| ACS | Auckland | New Zealand |
| Pusan National University Hospital | Busan | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
| King's College Hospital | London | United Kingdom |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided