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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study was a single-center study, including randomized, double-blind, placebo-controlled, single-dose escalation study, multiple-dose study, food effect on pharmacokinetics and drug metabolism transformation study, drug interaction study. To evaluate the tolerability, pharmacokinetics and metabolic transformation of TQA3810 in healthy subjects after single or multiple doses of TQA3810, the drug-drug interactions between TQA3810 tablets and entecavir dispersible tablets, and the pharmacokinetic properties of TQA3810 tablets in combination.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5mg single-dose | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| 1.0mg single-dose | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| Food impact group | Other | Sixteen subjects were enrolled and all received the trial drug. |
|
| 0.1mg single-dose | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| 0.3mg single-dose | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| Drug interaction group | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQA3810 | Drug | TQA3810 is a small-molecule Toll-like receptor (TLR8) agonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | Occurrence of all adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TEAEs) were recorded. | From the subject signed the informed consent form to 30 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma drug concentration | Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose |
| Tmax | To maximum plasma drug concentration time. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University | Nanjing | Jiangsu | 210008 | China |
Not provided
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Sixteen subjects were enrolled and all received the trial drug.
|
| 0.1mg multiple dosing | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| 0.3mg multiple dosing | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| 0.5mg multiple dosing | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| 0.2mg multiple dosing | Placebo Comparator | Ten subjects were enrolled, of whom 8 received the trial drug and 2 received placebo. |
|
| Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose |
| Half-life (t1/2) | Drug half-life in plasma. | Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose |
| AUC0-t | Plasma drug concentration from time 0 to the last measurable area under the drug concentration time curve. | Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose |
| AUC0-∞ | Area under the plasma drug concentration time curve from time 0 to infinity. | Single dose escalation study: within 60 minutes pre-dose of day 1; 5, 10, 20, 30, 45 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 7, and 12 hours post-dose |
| 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 |