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This is a randomized, double-blind, placebo-controlled, single ascending dose phase I clinical study to evaluate the safety, tolerability, PK and immunogenicity of SSGJ-626 in healthy adult subjects after single subcutaneous injection.
Six dose groups are planned for dose escalation in this study. Subjects in all dose groups will receive a single subcutaneous injection. Group S1 follows open-labeled, single-arm design, Groups S2 to S6 follow randomized, double-blinded, placebo-control design. Blood samples will be collected for PK, immunogenicity, biomarkers, laboratory tests, etc. according to the study schedule throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 626 Group S1 for subcutaneous injection | Experimental | dose level 1 of 626 |
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| 626 Group S2 for subcutaneous injection | Experimental | dose level 2 of 626 |
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| 626 Group S3 for subcutaneous injection | Experimental | dose level 3 of 626 |
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| 626 Group S4 for subcutaneous injection | Experimental | dose level 4 of 626 |
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| 626 Group S5 for subcutaneous injection | Experimental | dose level 5 of 626 |
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| 626 Group S6 for subcutaneous injection | Experimental | dose level 6 of 626 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 626 | Drug | Single subcutaneous injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | Incidence of adverse events will be summarized by SOC and PT for each treatment group, and also be summarized by severity and association with the study treatments. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak concentration (Cmax) will be calculated. | 90 days |
| Tmax | Time to peak concentration (Tmax) will be calculated. | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | 200080 | China |
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| Placebo | Drug | Single subcutaneous injection |
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| AUC0-last | Area under the concentration-time curve from time 0 to the time point of last measurable concentration post-dose (AUC0-last) will be calculated. | 90 days |
| Incidence of Anti-Drug Antibody | Anti-drug antibody (ADA) positive rate and titer will be calculated. Incidence of neutralizing antibody (Nab) if ADA is positive. | 90 days |