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This project is divided into a single dose escalation and a multiple dose escalation phase Ia clinical study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQH2929 injection in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQH2929 Injection (1 mg/kg) | Experimental | TQH2929 Injection 1 mg/kg is administered as a single dose. |
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| TQH2929 Injection (3 mg/kg) | Experimental | TQH2929 Injection 3 mg/kg is administered as a single dose. |
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| TQH2929 Injection (10 mg/kg) | Experimental | TQH2929 Injection 10 mg/kg is administered as a single dose. |
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| TQH2929 Injection (20 mg/kg) | Experimental | TQH2929 Injection 20 mg/kg is administered as a single dose. |
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| TQH2929 Injection (30 mg/kg) | Experimental | TQH2929 Injection 30 mg/kg is administered as a single dose. |
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| Placebo Injection | Placebo Comparator | Placebo injection is administered as a single dose or multiple doses (once every two weeks). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQH2929 injection | Drug | TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AE) rate | The occurrence of all adverse events (AE). | Single dose: Up to Day 113 |
| Serious adverse events (SAE) rate | The occurrence of all adverse events (SAE). | Single dose: Up to Day 113 |
| Treatment-related adverse events (TRAE) rate | The occurrence of all treatment-related adverse events (TRAE). | Single dose: Up to Day 113 |
| Incidence of clinical laboratory abnormalities | Proportion of subjects with clinical laboratory abnormalities | Single administration dose (SAD) group: up to Day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum observed serum concentration (Tmax), SAD | Time to reach maximum (peak) serum concentration after administration in SAD group | 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Maximum serum concentration (Cmax), SAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | 100871 | China |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Placebo injection | Drug | Placebo comparator |
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The maximum observed serum concentration of study drug in SAD group. |
| 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Area under the concentration-time curve from zero to infinity (AUC 0-∞), SAD | Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity in SAD group. | 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Area under the concentration-time curve from 0 to last observation (AUC 0-t), SAD | Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data time-point in SAD group. | 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Apparent volume of distribution (Vd/F), SAD | Apparent volume of distribution of the TQH2929 Injection in serum in SAD group. | 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Apparent clearance (CL/F), SAD | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body, in SAD group. | 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Half-life (t1/2), SAD | The time required for half of the drug to be eliminated from the serum in SAD group. | 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose. |
| Anti-drug antibodies (ADA) | Proportion of subjects with a positive ADA reading at any time point during the study. | SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113. |