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This is a single-center, randomized, double-blind, single-administration, escalating-dose, placebo-controlled, phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of SSS40 in healthy subjects in China.
A total of 8 subcutaneous dose groups were planned, including 1mg, 3mg, 10mg, 20mg, 30mg, 45mg, 60mg, 80mg. Starting from the 10mg group, a sentinel approach was adopted, whereby 2 subjects were first enrolled in the group, and randomized to the sentinel group in a 1:1 ratio (test drug:placebo), with the sentinels blinded, and then the remaining subjects in the group were randomized according to a 1:1 ratio (test drug:placebo), and the sentinel group was blinded. After completion of the 72-h safety assessment in the sentinel group, the remaining subjects in the group were randomized to receive the drug according to the test drug group and the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1mg dose group | Experimental | The 1mg dose group is a low dose group and only safety and tolerability will be evaluated, pharmacokinetics and immunogenicity will not be evaluated, therefore one subject is planned to be enrolled.1mg SSS40 was injected subcutaneously on day1. |
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| 3mg dose group | Experimental | Four subjects were included in the 3mg dose group (trial group: 3:1 placebo group).3mg SSS40/Placebo was injected subcutaneously on day1. |
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| 10mg、20mg、30mg、 45mg、60mg or 80mg dose group | Experimental | Sentinel dosing was used starting with the 10 mg group, with two subjects first enrolled and randomized 1:1 (test drug:placebo) for sentinel dosing, with sentinels participating in blinding, and then after the sentinel group had completed the 72-h safety assessment, the rest of the subjects in the group were randomized to receive dosing according to the test drug group versus the placebo group.10mg、20mg、30mg、 45mg、60mg or 80mg SSS40/Placebo was injected subcutaneously on day1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSS40 | Drug | Subjects injected with SSS40 |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 57 days |
| Peak Plasma Concentration (Cmax) | Evaluation of Peak Plasma Concentration (Cmax) | up to 57 days |
| Area under the plasma concentration versus time curve (AUC)0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | up to 57 days |
| Area under the plasma concentration versus time curve (AUC)0-∞ | Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞ | up to 57 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Cao, doctor | Contact | 86-18661809090 | caoyu1767@126.com |
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Single-dose , dose escalation, placebo-controlled study
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| Placebo | Drug | Subjects injected with Placebo |
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