An Open-label, Single-ascending dose, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Subcutaneous Injection in Healthy Subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Subjects will receive a single low dose on day 1 following protocol requirements.
Subjects will receive a single high dose on day 1 following protocol requirements.
AltaSciences Clinical Kansas, Inc
Overland Park, Kansas, United States
Number of treatment-related adverse events as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: 50 days
Abnormal clinical laboratory values as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (blood hematology, blood chemistry, urinalysis, etc.)
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: 50 days
Abnormal vital signs as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials (body temperature, pulse rate, blood pressure and respiratory rate)
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: 50 days
Abnormal physical examination
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: 50 days
Abnormal electrocardiogram (ECG): heart rate, PR and QT intervals, QTcF and QRS duration
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: 50 days
Maximum plasma concentration (Cmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
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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 pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
Time of maximum concentration (Tmax)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
elimination half-life (t1/2)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
elimination rate constant of plasma drug concentration in terminal phase (λz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
last measurable concentration (Clast)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
mean residence time (MRT)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
clearance (CL)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
apparent volume of distribution (Vz)
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
Change from baseline in concentration of free C5a
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 subcutaneous injection in healthy subjects
Time frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
anti-drug antibody
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 subcutaneous injection in healthy subjects
Time frame: Pre-dose; after dose 336hours, 840hours, 1176hours