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The study is designed in two phases: single-dose administration and multiple-dose administration. A randomized, double-blind, placebo-controlled trial design was used to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity of TQC2938 injection in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC2938 Injection (52.5mg/0.35ml) | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous (SC) injection. |
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| TQC2938 Injection (210mg/1.4ml)-subcutaneous injection | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. |
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| TQC2938 Injection (210mg/1.4ml)-intravenous injection | Experimental | TQC2938 Injection is administered as a single dose of intravenous (IV) injection . |
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| TQC2938 Injection (420mg/2.8ml) | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. |
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| TQC2938 Injection (840mg/5.6ml)-subcutaneous injection | Experimental | TQC2938 Injection is administered as a single dose of subcutaneous injection. |
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| TQC2938 Injection (1260mg/8.4ml) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC2938 Injection | Drug | TQC2938 injection is a humanized monoclonal antibody that interfering with the signal cascade. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | The occurrence of all adverse events (AEs). | Single dose: Up to Day 113. Multiple doses: Up to Day 169 |
| Serious adverse events (SAEs) | The occurrence and incidence of all serious adverse events (SAEs). | Single dose: Up to Day 113. Multiple doses: Up to Day 169 |
| Clinical laboratory abnormalities | Incidence of abnormal clinical laboratory examination, vital signs, physical examination, 12-lead electrocardiogram, etc. | Single dose: Up to Day 113. Multiple doses: Up to Day 169 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum serum concentration (Cmax) of subcutaneous injection for single dose | The Cmax is the maximum observed serum concentration of study drug. | Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Experimental |
TQC2938 Injection is administered as a single dose of subcutaneous injection. |
|
| TQC2938 Injection (210mg/1.4ml)-subcutaneous injection-multiple doses | Experimental | TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. |
|
| TQC2938 Injection (840mg/5.6ml)-subcutaneous injection-multiple doses | Experimental | TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. |
|
| TQC2938 Injection (630mg/4.2ml) | Experimental | TQC2938 Injection is administered as a multiple doses of subcutaneous injection, once every 28 days, three times in total. |
|
| TQC2938 Placebo | Placebo Comparator | TQC2938 Placebo is administered as a single dose or multiple doses, once every 28 days, three times in total. |
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| TQC2938 Placebo | Drug | TQC2938 Placebo is a placebo comparator |
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| Maximum serum concentration (Cmax) of intravenous injection for single dose |
The Cmax is the maximum observed serum concentration of study drug. |
| Single dose: pre-dose (-1 to 0 hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose |
| Maximum serum concentration (Cmax) of subcutaneous injection for multiple doses | The Cmax is the maximum observed serum concentration of study drug. | Multiple doses: pre-dose (-1 to 0 hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose on multiple dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for single dose | Time to reach maximum (peak) serum concentration following drug administration. | Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose |
| Time to reach maximum observed serum concentration (Tmax) of intravenous injection for single dose | Time to reach maximum (peak) serum concentration following drug administration. | Single dose: pre-dose (-1 to 0hour), 0.5hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose |
| Time to reach maximum observed serum concentration (Tmax) of subcutaneous injection for multiple doses | Time to reach maximum (peak) serum concentration following drug administration. | Multiple doses: pre-dose (-1 to 0hour) of days 1, 29, 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504hours post-dose of days 1 and 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Minimum concentration of drug in serum at steady state (Cmin, ss) of subcutaneous injection for multiple doses | Cmin,ss is the minimum serum concentration at steady state. | Multiple doses: Pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of subcutaneous injection for single dose | Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point. | Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose |
| Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of intravenous injection for single dose | Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point. | Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose |
| Area under the concentration-time curve from 0 to last observation (AUC [0-t]) of of subcutaneous injection for multiple dose | Area under the concentration-time curve of the TQC2938 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data point. | Multiple doses: pre-dose(-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Maximum concentration of drug in serum at steady state (Cmax, ss) of subcutaneous injection for multiple doses | Cmax, ss is the peak serum concentration of TQC2938 Injection during dosing interval at steady state. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Time to maximum serum concentration at steady state (Tmax, ss) of subcutaneous injection | Tmax,ss is defined as time to reach the peak serum concentration at steady state for TQC2938 Injection. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Area under curve of steady state (AUCss) of subcutaneous injection | To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of TQC2938 Injection in serum. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Half-life (t1/2) of subcutaneous injection for single dose | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. | Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose |
| Half-life (t1/2) of intravenous injection for single dose | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. | Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose |
| Half-life (t1/2) of intravenous injection for multiple dose | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the serum. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Apparent volume of distribution (Vd/F) of subcutaneous injection for single dose | Apparent volume of distribution of the TQC2938 Injection in serum. | Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose |
| Apparent volume of distribution (Vd/F) of intravenous injection for single dose | Apparent volume of distribution of the TQC2938 Injection in serum. | Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose |
| Apparent volume of distribution (Vd/F) of subcutaneous injection for multiple dose | Apparent volume of distribution of the TQC2938 Injection in serum. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Apparent clearance (CL/F) of subcutaneous injection for single dose | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Single dose: pre-dose (-1 to 0 hour),1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352 and 2688 hours post-dose |
| Apparent clearance (CL/F) of intravenous injection for single dose | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Single dose: pre-dose (-1 to 0 hour), 0.5 hours after the start of administration, and 0,0.25, 0.5, 1, 2, 4, 8, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose |
| Apparent clearance (CL/F) of subcutaneous injection for multiple dose | Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Accumulation ratio (Rac) of subcutaneous injection for multiple dose | To evaluate the pharmacokinetics (PK) of multiple ascending doses (MAD) of TQC2938 Injection in serum. | Multiple doses: pre-dose (-1 to 0 hour) of day 1, day 29, day 57, and 1, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504 hours post-dose of day 1 and day 57, and 672, 1008, 1344, 1680, 2016, 2352, 2688 hours post-dose of day 57 |
| Anti-drug antibodies (ADA) | Incidence of ADA, a participant was considered ADA-positive across the study if they had a positive reading at any time point during the study. | Single dose: (-1 to 0 hour) (pre-dose), 672, 1344, 2016 and 2688 hours postdose. Multiple doses: (-1 to 0 hour) before the first,second and third administration, 1344 and 2688 hours after intravenous injection of Day 57 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |