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This is a phase I, randomized, double-blind, placebo-controlled, dose-escalating clinical study aimed at evaluating the safety of TQB3702 tablets following single and multiple doses administered to healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3702 tablets | Experimental | TQB3702 tables is administered as a single dose or multiple dose. |
|
| TQB3702 placebo | Placebo Comparator | TQB3702 placebo is administered as a single dose or multiple dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3702 tablets | Drug | TQB3702 tablets is administered as a single dose on day 1, or once daily on Days 1 to 7 on multiple dose. Dosage: 100mg, 150/200mg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events rate | Number of subjects with adverse events (AEs) and serious adverse events (SAEs), the evaluation criteria for the nature and severity of adverse events are based on the National Cancer Institute's CommonTerminology Criteria for Adverse Events (NCI CTCAE version 5.0). | 17 days |
| Abnormal laboratory test indicators | Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0. | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum observed plasma concentration (Tmax) | Time to reach maximum (peak) plasma concentration following drug administration. | 1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shilong Zhong, Doctor | Contact | 18620829696 | gdph_zhongsl@gd.gov.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong provincial people's hospital | Recruiting | Guangzhou | Guangdong | 519041 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| TQB3702 placebo | Drug | TQB3702 placebo contains no active substance. |
|
| Maximum Plasma Concentration (Cmax) | The Cmax is the maximum observed plasma concentration of TQB3702. | 1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose |
| Elimination half-life (t1/2) | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | 1 hour (pre-dose), 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 1 for sing dose and multiple dose. 0.5 hour pre-dose of day 4 to day 7, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 24 hours post-dose of Day 7 for multiple dose |