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
Overview
- Phase
- Phase 1
- Intervention
- STSA-1002 subcutaneous injection
- Conditions
- Antineutrophil Cytoplasmic Antibody Associated Vasculitis
- Sponsor
- Staidson (Beijing) Biopharmaceuticals Co., Ltd
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Abnormal physical examination
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects, aged ≥ 21 but ≤ 57, male and female.
- •Weight: 50-93 kg; Body mass index (BMI): 21～31 kg/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 6 months after the end of the study.
- •Female and/or male subjects those meet the below criteria:
- •If a female subject of childbearing potential - agrees to use one of the accepted contraceptive regimens from at least 30 days prior to administration of IMP, during the study, and for at least 6 months after the administration of IMP. An acceptable method of contraception includes one of the following:
- •Abstinence from heterosexual intercourse, if it is the preferred and usual lifestyle choice of the subject. Additionally, it should be noted that periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) is not an acceptable method of birth control; Hormonal contraceptives (birth 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) during the study and for at 6 months after the administration of IMP.
- •If a female subject of non-childbearing potential - should have been surgically sterilized at least 6 months before screening (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation/occlusion) or in the postmenopausal 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 6 months after the administration of IMP.
- •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 history of hypersensitivity or clinically significant allergic reaction to any drug, biologic, food or vaccine.
- •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.
- •Subjects who have participated in any vaccine clinical study or have received any live vaccine within 3 months prior to the IMP administration or plan to receive live vaccines during the study period, and subjects who have received inactivated or attenuated vaccines 28 days prior to the IMP administration or plan to receive inactivated or attenuated vaccines within 2 months after the end of the study. If the subject has received any SARS-CoV-2 vaccine prior to screening, enrollment must be delayed until the biologic impact of the vaccine is stabilized, as determined by discussion between the investigator and the sponsor.
Arms & Interventions
STSA-1002 subcutaneous injection: dose 2 (Second cohort)
Intervention: STSA-1002 subcutaneous injection
STSA-1002 subcutaneous injection: dose 1 (First cohort)
Intervention: STSA-1002 subcutaneous injection
Outcomes
Primary Outcomes
Abnormal physical examination
Time Frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Time of maximum concentration (Tmax)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
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.)
Time Frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
clearance (CL)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
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)
Time Frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection 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: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Number of treatment-related adverse events as assessed by toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials
Time Frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Abnormal electrocardiogram (ECG): heart rate, PR and QT intervals, QTcF and QRS duration
Time Frame: 50 days
To evaluate the safety and tolerability of STSA-1002 subcutaneous injection in healthy adult subjects
Maximum plasma concentration (Cmax)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
last measurable concentration (Clast)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
elimination half-life (t1/2)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
mean residence time (MRT)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
apparent volume of distribution (Vz)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
elimination rate constant of plasma drug concentration in terminal phase (λz)
Time Frame: Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 subcutaneous injection in healthy adult subjects
Secondary Outcomes
- anti-drug antibody(Pre-dose; after dose 336hours, 840hours, 1176hours)
- Change from baseline in concentration of free C5a(Pre-dose; after dose 8hours, 24hours, 48hours, 72hours, 96hours, 120hours, 168hours, 336hours, 504hours, 840hours, 1176hours)