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This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics.
In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQA3038 injection | Experimental | One dose of TQA3038 injection in Day 1. |
|
| TQA3038 injection matching placebo | Placebo Comparator | One dose of TQA3038 injection matching placebo in Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQA3038 injection | Drug | TQA3038 is an injection. |
| |
| 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. | Up to 85 days. |
| Number of subjects with clinically significant abnormalities | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. | Up to 85 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Maximum concentration of TQA3038 and its metabolite in plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose |
| Time to Reach Maximum Plasma Concentration (Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dong Liu, Doctor | Contact | +86 13507183749 | ld_2069@163.com | |
| ZheLong Liu, Doctor | Contact | +86 13986235028 | liuzhelong@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | 40030 | China |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| TQA3038 injection matching placebo |
| Drug |
Placebo injection contains no active substance. |
|
Time to reach Cmax of TQA3038 and its metabolite in plasma
| Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose |
| Area Under the Plasma Concentration Versus Time Curve (AUC) | Area under the curve of TQA3038 and its metabolite from time 0 to last measurable time | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose |
| Apparent Terminal Elimination Half-life (T1/2) | Apparent Elimination Half-life (T1/2) of TQA3038 in Plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose |
| Apparent Plasma Clearance (CL/F) | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma | Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose |
| Fraction eliminated in the urine | Apparent Plasma Clearance (CL/F) of TQA3038 in Plasma | Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1. |
| 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 |