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Phase 1 Study of HT-101 in Healthy Subjects and Patients With Chronic Hepatitis B The trial consisted of two components. Part A involved a single ascending dose study where healthy participants were administered one dose of HT-101 or placebo subcutaneously (SC). Part B involved a multiple ascending dose study where participants with chronic hepatitis B virus infection were administered two dose of HT-101 or placebo every 4 weeks subcutaneously (SC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | Single ascending Dose of HT-101 or placebo in Healthy participants subcustaneously. |
|
| Part B | Experimental | Multiple Ascending Dose of HT-101 or placebo in patients with Chronic hepatitis B virus subcustaneously. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HT-101 | Drug | Single dose of HT-101 administered subcutaneously. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. | From enrollment to the end of treatment at 24 weeks |
| Clinically significant abnormalities | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. | From enrollment to the end of treatment at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Cmax of HT-101 and its metabolite in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. |
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Inclusion Criteria: Subjects were eligible for inclusion into the study if they met each of the following criteria:
Part A SAD: Healthy Participant
Part B MAD: Patient with CHB
Exclusion Criteria:Subjects were excluded from the study if one or more of the following criteria were applicable
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital Capital Medical University | Beijing | Beijing Municipality | 100015 | China | ||
| Beijing Friendship Hospital |
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| HT-101 |
| Drug |
Multiple dose of HT-101 administered subcutaneously. |
|
| Placebo | Drug | Placebo, containing no active ingredient, administered subcutaneouly |
|
| From predose 0.5 hours to postdose 48 hours. |
| Time to Reach Maximum Plasma Concentration (Tmax) | Tmax of HT-101 and its metabolite in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. | From predose 0.5 hours to postdose 48 hours. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | AUC of HT-101 and its metabolite from time 0 to last measurable time. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours,1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours,1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. | From predose 0.5 hours to postdose 48 hours. |
| Apparent Terminal Elimination Half-life (T1/2) | T1/2 of HT-101 in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. | From predose 0.5 hours to postdose 48 hours. |
| Apparent Plasma Clearance (CL/F) | CL/F of HT-101 in plasma. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. | From predose 0.5 hours to postdose 48 hours. |
| apparent volume of distribution（Vd/F） | Vd/F of HT-101. First administration (Healty participants and Patients with CHB): Predose 0.5 hours; Postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. Second administration (Patients with CHB): Predose 0.5 hours; postdose 0.5 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 24 hours and 48 hours. | From predose 0.5 hours to postdose 48 hours. |
| Maximum Change of Serum HBsAg From Baseline | Maximum change of serum HBsAg from Day 1 until 24 weeks post last dose (negative values mean reductions from baseline, positive values mean increased from baseline) | Up to 24 weeks |
| Maximum Change of Serum HBV DNA From Baseline | Maximum change of serum HBV DNA from Day 1 until 24 weeks (negative values mean reductions from baseline, positive values mean increased from baseline). | Up to 24 weeks |
| Number of participants with HBeAg Loss | For HBeAg-positive Participants: Number of Subjects With HBeAg Loss | Up to 24 weeks |
| Beijing |
| Beijing Municipality |
| 100050 |
| China |
| Nanfang Hospital | Guangzhou | Guangdong | 510515 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221132 | China |
| The First Bethune Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Yanbian University Hospital | Yanji | Jilin | 133000 | China |
| Shanghai Public Health Clinical Center | Shanghai | Shanghai Municipality | 200083 | China |
| 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 |
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