A Randomized,Double-blind,Placebo-controlled,Single-ascending Dose Phase Ⅰa Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of STSA-1002 Following Intravenous Infusion in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- STSA-1002 injection
- Conditions
- Healthy
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Area under the plasma concentration-time curve from time 0 to infinity(AUC0-∞)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
A randomized,double-blind,placebo-controlled,single-ascending dose phase Ⅰa study to evaluate the safety,tolerability,pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects,aged ≥18 but ≤65，male and female.
- •Body mass index:18.0～32.0kg/m²，inclusive.
- •Subjects(including their partners) agree to take highly effective contraceptive measures during the study,and they have no birth plan or sperm donation plan within 3months after the end of the study.
- •Female and/or male subjects those meet the below criteria:
- •If a female subject of child bearing potential-agrees to use one of the accepted contraceptive regimens from at least 30 days prior to the administration of IMP,during the study,and for at least 3 months after the end of the study. An acceptable method of contraception includes one of the following:
- •Abstinence from heterosexual intercourse Hormonal contraceptives(brith control pills,injectable/implant/insertable hormonal birth control products, transdermal patch) Intrauterine device(with or without hormones) OR agrees to use a double barrier method (e.g. condom and spermicide) . If a female subject of non-childbearing potential - should be surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in a menopausal state (at least 1 year without menses), as confirmed by Follicle-stimulating hormone (FSH) levels (≥ 40 mIU/mL).
- •A male subject that engages in sexual activity that has the risk of pregnancy must agree to use a double barrier method (e.g. condom and spermicide) and agree to not donate sperm during the study and for at least 3 months after the end of the study.
- •Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects show normal results or mild abnormalities with no clinical significance before enrollment, and the Investigator judges that they are eligible.
- •Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).
Exclusion Criteria
- •History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study.
- •History of tuberculosis or a recent history of infection within the past 4 weeks.
- •History of recurrent infections.
- •Presence of clinically significant laboratory values during the screening period, as defined by an Investigator.
- •Presence of clinically significant vital signs values or of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator.
- •Subjects who have autoimmune disease or immunodeficiency, or have a family history of related diseases.
- •Subjects who have allergies, or have or are currently suffering from clinically significant atopic allergies, hypersensitivity or allergic reactions, including known or suspected clinically relevant hypersensitivity or allergic reactions to certain components of the IMP preparation, or a history of allergies to other drugs or biological agents.
- •Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb).
- •Subjects who have received treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening or 90 days for biologic compounds prior to screening.
- •Subjects who have participated in any vaccine clinical study as subjects within 3 months before enrollment or plan to receive live vaccines during the study period, and subjects who have received vaccines 28 days prior to the IMP administration or plan to receive vaccines within 2 months after the end of the study.
Arms & Interventions
Cohort 5:30mg/kg
All participants (fasted) received either 30mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: STSA-1002 injection
Cohort 5:30mg/kg
All participants (fasted) received either 30mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: Placebo
Cohort 1:2mg/kg
All participants (fasted) received either 2mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: STSA-1002 injection
Cohort 1:2mg/kg
All participants (fasted) received either 2mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: Placebo
Cohort 2:5mg/kg
All participants (fasted) received either 5mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: STSA-1002 injection
Cohort 2:5mg/kg
All participants (fasted) received either 5mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: Placebo
Cohort 3:10mg/kg
All participants (fasted) received either 10mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: STSA-1002 injection
Cohort 3:10mg/kg
All participants (fasted) received either 10mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: Placebo
Cohort 4:20mg/kg
All participants (fasted) received either 20mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: STSA-1002 injection
Cohort 4:20mg/kg
All participants (fasted) received either 20mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Area under the plasma concentration-time curve from time 0 to infinity(AUC0-∞)
Time Frame: Up to 1200 hours postdose
Time of maximum concentration(Tmax)
Time Frame: Up to 1200 hours postdose
Elimination rate constant of plasma drug concentration in terminal phase(λz)
Time Frame: Up to 1200 hours postdose
Last measurable concentration(Clast)
Time Frame: Up to 1200 hours postdose
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities,Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities
Time Frame: Day 1 through Day 51
Maximum plasma concentration(Cmax)
Time Frame: Up to 1200 hours postdose
Area under the plasma concentration-time curve from time 0 to the collection time point of the last measurable concentration(AUC 0-t)
Time Frame: Up to 1200 hours postdose
Elimination half-life(t1/2)
Time Frame: Up to 1200 hours postdose
Mean residence time(MRT)
Time Frame: Up to 1200 hours postdose
Clearance(CL)
Time Frame: Up to 1200 hours postdose
Apparent volume of distribution(Vz)
Time Frame: Up to 1200 hours postdose
Secondary Outcomes
- Change from baseline in concentration of free C5a and anti-drug antibody(Up to 1200 hours postdose)
- Change from baseline in concentration of CH50,IL-6,IL-8,TNF-α,IFN-γ(Up to 1200 hours postdose)