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Due to the COVID-19 epidemic situation, the sponsor has decided to terminate the project.
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An open-label, single-ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 combined with STSA-1005 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STSA-1002 and STSA-1005 dose level 1 | Experimental |
| |
| STSA-1002 and STSA-1005 dose level 2 | Experimental |
| |
| STSA-1002 and STSA-1005 dose level 3 | Experimental |
| |
| STSA-1002 and STSA-1005 dose level 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSA-1002 Injection | Drug | Intravenous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities. | To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects. | 56 days |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344hours postdose |
| Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fengxue Guo, Bachelor | The Second Affiliated Hospital of Xingtai Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Of Xingtai Medical College | Xingtai | Hebei | 054000 | China |
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| STSA-1005 Injection | Drug | Intravenous injection |
|
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Up to 1344 hours postdose |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344 hours postdose |
| Time of maximum concentration (Tmax) | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344hours postdose |
| Elimination half-life (t1/2). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344 hours postdose |
| Elimination rate constant (Kel). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344 hours postdose |
| Clearance (CL). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344 hours postdose |
| Apparent volume of distribution (Vz). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344 hours postdose |
| Mean residence time (MRTlast). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344 hours postdose |
| Extrapolated area under the curve (AUC_%Extrap). | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. | Up to 1344hours postdose |
| Change from baseline in concentration of free C5a and anti-drug antibody. | To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 combined with STSA-1005 in healthy subjects. | Up to 1344 hours postdose |
| Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF). | To evaluate the effects of STSA-1002 combined with STSA-1005 on cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF). | Up to 1344 hours postdose |