A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Single-ascending Dose Phase I Study to Evaluate the Safety and Tolerability of STSA-1002 Combined With STSA-1005 in Healthy Subjects

Conditions
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Healthy Subject

Intervention / Treatment
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* Drug: STSA-1002 Injection
* Drug: STSA-1005 Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects, aged ≥ 18 but ≤ 45, male and female; Weight: Male≥50.0kg, Female ≥ 45kg; Body mass index: 19.0-26.0 kg/m2, inclusive; Subjects (including their partners) must take effective contraceptive measures and have no birth plan or sperm or egg donation plan during the trial period and within 6 months after the end of the last administration; The subjects were aware of the risks of the trial, voluntarily participated in the study and signed the informed consent form (ICF). Exclusion Criteria: Have a history of serious disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular diseases) or have undergone any major surgery within 2 months prior to screening; The investigators determined that abnormalities in pre-enrollment physical examinations, laboratory tests, and trial-related tests were clinically significant; A definite history of food or drug allergies; Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb); History of tuberculosis; or combined with T-SPOT.TB results, low-dose chest CT comprehensive evaluation of tuberculosis infection; Hemoglobin was lower than the lower limit of normal value during the screening period; Smoking more than 5 or equivalent cigarettes per day in the 3 months before screening; Regular drinkers in the 6 months prior to screening, i.e. those who have consumed more than 2 units of alcohol per day (1 unit =360ml beer or 45ml spirits with an alcohol concentration of 40% or 150ml wine) in the 6 months prior to screening or have a positive alcohol test result; Subjects with a history of substance abuse within 1 year before screening or have a positive drug test result; Blood loss or blood donation > 400ml three months before screening, or blood transfusion history within 4 weeks before inclusion; Participate in clinical trials of new drugs or vaccines as a subject within 3 months prior to screening； Vaccination was given within 1 month before screening or planned between the study period and 2 months after the end of the study; Use of medications that may affect immune function in the 6 months prior to screening or any monoclonal antibody or biologic treatment in the 3 months prior to screening and use of prescription drugs/over-the-counter drugs or herbal medicines in the 14 days prior to screening； Drink more than 5 cups of coffee, tea or cola (150ml or more per cup) daily within 3 months before screening; Pregnant or lactating women; A history of blood and needle sickness； Other circumstances in which the investigator considers it inappropriate to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STSA-1002 and STSA-1005 dose level 1<br> | Drug: STSA-1002 Injection<br>* Intravenous injection<br>Drug: STSA-1005 Injection<br>* Intravenous injection<br>|
| Experimental: STSA-1002 and STSA-1005 dose level 2<br> | Drug: STSA-1002 Injection<br>* Intravenous injection<br>Drug: STSA-1005 Injection<br>* Intravenous injection<br>|
| Experimental: STSA-1002 and STSA-1005 dose level 3<br> | Drug: STSA-1002 Injection<br>* Intravenous injection<br>Drug: STSA-1005 Injection<br>* Intravenous injection<br>|
| Experimental: STSA-1002 and STSA-1005 dose level 4<br> | Drug: STSA-1002 Injection<br>* Intravenous injection<br>Drug: STSA-1005 Injection<br>* Intravenous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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). | 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 |