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This is the first-in-human phase 1 trial of TQC2731 injection in healthy subjects and in patients with severe asthma to evaluate the safety, tolerability, pharmacokinetic characteristics and immunogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQC2731 injection(sc.) in healthy subjects | Experimental | For the single ascending dose (SAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of TQC2731(12mg、105mg、210mg、420mg、630mg) once. For the multiple ascending dose (MAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of 420mg TQC2731 . |
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| Matching Placebo(sc.) in healthy subjects | Placebo Comparator | For the single ascending dose (SAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of matching placebo(12mg、105mg、210mg、420mg、630mg) once. For the multiple ascending dose (MAD) portion of the study, healthy subjects received subcutaneous(sc.) injection of 420mg matching placebo(12mg、105mg、210mg、420mg、630mg). |
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| TQC2731 injection(SAD,iv.) | Experimental | Healthy subjects received 210mg TQC2731 intravenously (iv.) once. |
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| Matching Placebo(SAD,iv.) | Placebo Comparator | Healthy subjects received 210mg matching placebo intravenously (iv.) once. |
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| TQC2731 injection(sc.) in asthma subjects | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQC2731 | Drug | TQC2731 injection |
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| Measure | Description | Time Frame |
|---|---|---|
| (healthy subject)Number of participants with abnormal clinical symptoms | appropriatly up to Day 253 | |
| (healthy subject)Number of participants with abnormal physical examination | appropriatly up to Day 253 | |
| (healthy subject)Number of participants with abnormal vital signs | appropriatly up to Day 253 | |
| (asthma subject)Number of participants with abnormal laboratory examinations | appropriatly up to Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the drug-time curve | up to Day 253 | |
| Maximum Concentration | up to Day 253 | |
| Time to maximum concentration following drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaojian Zhang, Bachelor | Contact | +86-0371-66295651 | Zhxj0524@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhengzhou University | Henan | Zhengzhou | 450052 | China |
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For the multiple ascending dose (MAD) portion of the study, asthma subjects received subcutaneous(sc.) injection of TQC2731(70mg、210mg、280mg) .
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| Matching Placebo(sc.) in asthma subjects | Placebo Comparator | For the multiple ascending dose (MAD) portion of the study, asthma subjects received subcutaneous(sc.) injection of matching placebo(70mg、210mg、280mg) . |
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| Placebo | Drug | Matching placebo with no active ingredients |
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| up to Day 253 |
| Apparent terminal elimination half-life following drug administration | up to Day 253 |
| Apparent volume of distribution | up to Day 253 |
| Clearance rate | up to Day 253 |
| Incidence and titer of anti-drug antibody (ADA) | up to Day 253 |
| Changes in forced expiratory volume (FEV1) in the first second before bronchodilator (before BD administration) from baseline | up to Day 253 |
| Changes in exhaled nitric oxide FENO (ppb) in the first second before bronchodilator (before BD administration) from baseline | up to Day 253 |
| exhaled nitric oxide FENO (ppb), peripheral blood eosinophils, and total serum IgE | up to Day 253 |
| Annualized incidence of acute asthma attack (AAER) and degree | up to Day 253 |