A Randomized,Double-blind, Placebo-controlled, Multiple Ascending-Dose Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002 Injection in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- STSA-1002 Injection
- Conditions
- Healthy Subject
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a Phase Ib, randomized, double-blind, placebo-controlled, multiple dose, dose escalation safety, tolerability,pharmacokinetic and pharmacodynamic study of STSA-1002 injection in healthy subjects. A total of 26 healthy subjects were enrolled in three dosage groups.
Investigators
Eligibility Criteria
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.
- •Medical history, vital signs, physical examination, laboratory examination (including blood routine, urine routine, blood biochemistry, coagulation function test, etc.) and all tests related to the test were normal or abnormal as determined by the researcher and had no clinical significance.
- •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.
- •Subjects are aware of the content, process and possible adverse reactions of the study and voluntarily signed the informed consent form(ICF).
Exclusion Criteria
- •History of tuberculosis; or combined with mixed lymphocyte culture + interferon assay results, chest imaging comprehensive evaluation of tuberculosis infection (if necessary, tuberculosis experts should be jointly evaluated).
- •Any clinically serious diseases such as respiratory, circulatory, digestive, urinary, blood, endocrine, neurological or mental disorder, or a history of the above diseases or any other diseases or physiological conditions that can interfere with the test results.
- •With any major surgical or surgical that possibly affects drug absorption, distribution, metabolism or excretion(Except appendicitis) within 2 months before screening or plan to undergo surgery during the study period.
- •Subjects with allergies or allergies to any components of the investigational drug and its excipients(such as allergies to two or more drugs, food, pollen), or the IgE is higher than the upper limit of normal.
- •Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
- •Subjects with abnormal blood white blood cell count and absolute neutrophil count during the screening period with clinical significance; or hemoglobin: male \<120g/L or female \<110g/L.
- •Drug abuse within 1 year before screening \[such as morphine, ketamine (K powder), THC (marijuana), methamphetamine (ice), MDMA (ecstasy) ), cocaine, etc.\]; or positive urine screening for drug abuse.
- •Subjects who have taken drugs that may affect immune function within 6 months before screening, have received any monoclonal antibody or biological agent for treatment (for any illness) within the previous 3 months, and have taken prescription drugs,non-prescription drugs,chinese herbal medicine within 14 days before screening.
- •Alcoholism within 6 months before screening (drinking more than 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 100mL of wine) or unable to stop consuming any alcoholic products after enrollment until the entire study period or a positive alcohol breath test result.
- •Subjects who smoking (more than 5 cigarettes per day on average) within 3 months before screening or who could not stop using any tobacco products until the whole study period after enrollment.
Arms & Interventions
A low dose of group
All subjects will be randomized to receive low dose of STSA-1002 or dose-matched placebo.
Intervention: STSA-1002 Injection
A low dose of group
All subjects will be randomized to receive low dose of STSA-1002 or dose-matched placebo.
Intervention: Placebo
A middle dose of group
All subjects will be randomized to receive middle dose of STSA-1002 or dose-matched placebo.
Intervention: STSA-1002 Injection
A middle dose of group
All subjects will be randomized to receive middle dose of STSA-1002 or dose-matched placebo.
Intervention: Placebo
A high dose of group
All subjects will be randomized to receive high dose of STSA-1002 or dose-matched placebo.
Intervention: STSA-1002 Injection
A high dose of group
All subjects will be randomized to receive high dose of STSA-1002 or dose-matched placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Time of maximum concentration (Tmax)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Incidence of Adverse Events、Clinically Significant Laboratory Abnormalities、Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
Time Frame: Up to Study Day 56
To evaluate the safety and tolerability of multiple intravenous administration of STSA-1002 in healthy adult subjects.
Apparent volume of distribution (Vz)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Maximum Concentration of the Analyte in Plasma at steady state(Cmax, ss)
Time Frame: From Day 0 to Day 56
To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects
Clearance (CL)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Maximum plasma concentration (Cmax)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 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)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Accumulation factor
Time Frame: From Day 0 to Day 56
To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects
Mean residence time (MRT)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Minimum Measured Concentration of the Analyte in Plasma at Steady State(Cmin, ss)
Time Frame: From Day 0 to Day 56
To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects
Time-averaged concentration at steady state(Cav, ss)
Time Frame: From Day 0 to Day 56
To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects
Elimination half-life (t1/2)
Time Frame: From Day 0 to Day 56
To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Area under the concentration curve from time 0 extrapolate to infinite time(AUCinf,ss)
Time Frame: From Day 0 to Day 56
To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects
Degree of fluctuation(DF)
Time Frame: From Day 0 to Day 56
To evaluate the multidose PK characteristics of STSA-1002 in healthy adult subjects
Secondary Outcomes
- Change from baseline in concentration of free C5a and anti-drug antibody(From Day 0 to Day 56)
- Change from baseline in concentration of Myeloperoxidase（MPO）、Neutrophil elastase（NE）、Proteinase3（PR3）、 C-X-C chemokine receptor 1(CXCR1)(From Day 0 to Day 56)