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| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
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This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by single subcutaneous injection with six different doses in healthy subjects. There are 6 groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 ~ S6 groups (of which 8 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 610 group | Experimental | Participants will be administered with 0.03mg/kg, 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg of 610 by subcutaneous injection. Subjects will be followed for 84 days. |
|
| controll group | Placebo Comparator | Participants will be administered with 0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 5.0mg/kg, 7.5mg/kg placebo once by subcutaneous injection. Subjects will be followed for 84 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 610 | Drug | Recombinant anti-IL-5 Humanized Monoclonal Antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Plasma Concentration of 610 | up to 84 days |
| Tmax | Time to Maximum Plasma Concentration of 610 | up to 84 days |
| AUC | Area Under the Curve of 610 | up to 84 days |
| t1/2 | Half life of 610 in blood | up to 84 days |
| CL/F | Plasma clearance of 610 | up to 84 days |
| Vd/F | Apparent Volume of Distribution of 610 | up to 84 days |
| AE | To monitor adverse events (AEs) per the NCI CTCAE 5.0. | up to 84 days |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity | Percentage of ADA positive and determination of ADA titer as well as Nab | up to 84 days |
| EOS | Compare the changes of EOS levels with the baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Chou, B.M. | Contact | 13701756821 | 13701756821@163.com | |
| Xueying Ding, D.M. | Contact | 13761642319 | dingxueying@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Xueying Ding, D.M. | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | 200080 | China |
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| Placebo |
| Drug |
Placebo |
|
| up to 84 days |