Healthy Subject
Conditions
Brief summary
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.
Interventions
Intravenous injection
Intravenous injection
Sponsors
Staidson (Beijing) Biopharmaceuticals Co., Ltd
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities. | 56 days | To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax). | Up to 1344hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Time of maximum concentration (Tmax) | Up to 1344hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Elimination rate constant (Kel). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Elimination half-life (t1/2). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Apparent volume of distribution (Vz). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Mean residence time (MRTlast). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Extrapolated area under the curve (AUC_%Extrap). | Up to 1344hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
| Change from baseline in concentration of free C5a and anti-drug antibody. | Up to 1344 hours postdose | To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 combined with STSA-1005 in healthy subjects. |
| Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF). | Up to 1344 hours postdose | 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). |
| Clearance (CL). | Up to 1344 hours postdose | To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects. |
Countries
China
Outcome results
None listed