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This study is a randomized, double-blind, placebo-controlled Phase I clinical study of TQ-A3334 tablets in adult healthy subjects, and the trial is planned to enroll 60 healthy subjects.
The primary objective is to evaluate the safety and tolerability of multiple dosing of TQ-A3334 tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-A3334 tablets (once a day) | Experimental | TQ-A3334 tablets, administered once a day. |
|
| TQ-A3334 placebo tablets (once a day) | Placebo Comparator | TQ-A3334 placebo tablets, administered once a day. |
|
| TQ-A3334 tablets (every other day) | Experimental | TQ-A3334 tablets, administered once every other day. |
|
| TQ-A3334 placebo tablets (every other day) | Placebo Comparator | TQ-A3334 placebo tablets, administered once every other day. |
|
| TQ-A3334 tablets (every three days) | Experimental | TQ-A3334 tablets, administered once every three days. |
|
| TQ-A3334 placebo tablets (every three days) | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-A3334 tablets | Drug | TQ-A3334 tablet is a Toll like receptor 7 (TLR7) agonist. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AE) | Incidence of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | From patient enrollment to withdrawal, estimated to be around 1 month. |
| Severity of adverse events (AE) | Severity of adverse events (AE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | From patient enrollment to withdrawal, estimated to be around 1 month. |
| Incidence of serious adverse events (SAE) | Incidence of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | From patient enrollment to withdrawal, estimated to be around 1 month. |
| Severity of serious adverse events (SAE) | Severity of serious adverse events (SAE) evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. | From patient enrollment to withdrawal, estimated to be around 1 month. |
| Tolerability after drug administration | Tolerability is evaluated by the number of participants with abnormal laboratory examinations, vital signs, physical examination, electrocardiogram. | From patient enrollment to withdrawal, estimated to be around 1 month. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Time (Tmax) | The time required to reach the highest concentration (peak drug concentration) on the human blood concentration curve after administration. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Peak concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Changchun | Jilin | 130021 | China |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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TQ-A3334 placebo tablets, administered once every three days.
|
| TQ-A3334 placebo tablets | Drug | TQ-A3334 placebo tablet is a placebo that has no effect on TLR7. |
|
The highest blood drug concentration achieved after administration. |
| From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Plasma concentration-area under time curve (AUC0-24) | The area under the plasma concentration-time curve from the beginning of the first administration to 24 hours. | From 60 minutes before administration on Day 1 to 24 hours after the last administration. |
| Plasma concentration-area under time curve (AUC0-24) | The area under the plasma concentration-time curve from the beginning of the first administration to the last measurable concentration point. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Plasma concentration-area under time curve (AUC0-∞) | Extrapolated from the first administration to the area under the plasma concentration-time curve to infinity. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Apparent volume of distribution (Vd/F) | The ratio of the drug dosage in the body to the blood drug concentration when the drug reaches dynamic equilibrium in the body. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Clearance (CL/F) | Ratio of drug clearance rate to administration concentration. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Elimination half-life time (t1/2) | The time it takes to reduce the concentration of drugs in the blood by half | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Time of maximum concentration under steady state (Tmax,ss) | Time required to reach steady-state peak concentration after administration. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Maximum concentration under steady state (Cmax, ss) | The highest blood drug concentration that occurs after reaching steady state. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Minimum concentration under steady state (Cmin, ss) | The lowest blood drug concentration that occurs after reaching steady state. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Plasma concentration at steady state (Cav, SS) | The plasma concentration at which the rate of administration and rate of elimination are in equilibrium. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Plasma concentration area under steady-state time curve (AUCss) | The area under the plasma concentration-time curve of the steady state. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Accumulation Index (Rac) | The ratio of steady-state blood drug concentration to blood drug concentration after the first administration. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Degree of fluctuation (DF) | The ratio of the difference between the maximum steady-state blood drug concentration and the minimum steady-state blood drug concentration to the average steady-state blood drug concentration. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Interferon-α concentration (IFN-α) | The change of subjects' blood IFN-α concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Interferon-stimulated gene concentration (ISG) | The change of subjects' blood ISG concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Interferon-gamma concentration (IFN-γ) | The change of subjects' blood IFN-γ concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Tumor Necrosis Factor-α concentration (TNF-α) | The change of subjects' blood TNF-α concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Interleukin-6 concentration (IL-6) | The change of subjects' blood IL-6 concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Interleukin-2 concentration (IL-2) | The change of subjects' blood IL-2 concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Monocyte Chemotactic Protein 1 concentration (MCP-1) | The change of subjects' blood MCP-1 concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| Interferon-inducible protein-10 concentration (IP-10) | The change of subjects' blood IP-10 concentration from baseline. | From 60 minutes before administration on Day 1 to 72 hours after the last administration. |
| QT/QT interval | Level of change in QT/QT interval to evaluate the drug cardiotoxicity. | From 30 minutes before administration on Day 1 to 48 hours after the last administration. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |