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This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability and pharmacokinetics of STSA-1005 in healthy participants. Four kinds different doses and dose-matched placebo were administered under fasted conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1:1mg/kg | Experimental | All participants (fasted) received either 1mg/kg of STSA-1005 as a single dose or dose-matched placebo. |
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| Cohort 2:2.5mg/kg | Experimental | All participants (fasted) received either 2.5mg/kg of STSA-1005 as a single dose or dose-matched placebo. |
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| Cohort 3:5mg/kg | Experimental | All participants (fasted) received either 5 mg/kg of STSA-1005 as a single dose or dose-matched placebo. |
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| Cohort 4:10mg/kg | Experimental | All participants (fasted) received either 10 mg/kg of STSA-1005 as a single dose or dose-matched placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STSA-1005 injection | Drug | Intravenous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events, Serious Adverse Events, Clinically Significant Laboratory Abnormalities, Electrocardiogram Abnormalities, Vital Signs Abnormalities and Physical Examination Abnormalities. | Day 1 through Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t) |
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Inclusion Criteria:
Subjects are able to understand and are willing to sign the informed consent form (ICF).
Subjects (male or female) must be ≥18 to ≤65years of age inclusive.
Healthy subjects according to the results of medical history, physical examination, vital signs, ECG, and clinical laboratory examination. The Investigator considers that the subjects are in good health with no clinically significant heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders, and metabolic disorders.
Subjects with a body mass index (BMI) of 20-32kg/m^2, inclusive.
(1)If a subject is a female of childbearing potential - she should agree to use one of the accepted contraceptive regimens from at least 30 days before screening, during the study, and for at least 3 months after administration of the study treatment.1)An acceptable method of contraception includes one of the following:
Abstinence from heterosexual intercourse;
Hormonal contraceptives (birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch);
Intrauterine device (with or without hormones). 2)OR she should agree to use a double-barrier method (e.g., condom and spermicide) during the study and for at least 3 months after administration of the study treatment.
(2)If a subject is a female of non-childbearing potential - she 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 study 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 90 days after administration of the study treatment.
Subjects understand the risks of the study, can comply with the study protocol, and complete the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AltaSciences Clinical Kansas, Inc | Overland Park | Kansas | 66212 | United States |
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| Drug |
Intravenous injection |
|
| STSA-1005 injection | Drug | Intravenous injection |
|
| Placebo | Drug | Intravenous injection |
|
| STSA-1005 injection | Drug | Intravenous injection |
|
| Placebo | Drug | Intravenous injection |
|
| STSA-1005 injection | Drug | Intravenous injection |
|
| Placebo | Drug | Intravenous injection |
|
To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects |
| Up to 1344 hours postdose |
| Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Time of maximum concentration (Tmax) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Elimination half-life (t1/2) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Fraction of drug eliminated per unit of time (Kel) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Last measurable concentration (Clast) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Mean residence time (MRT) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Clearance (CL) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| Apparent volume of distribution (Vz/F) | To evaluate the pharmacokinetics (PK) characteristics of STSA-1005 in healthy adult subjects | Up to 1344 hours postdose |
| The number of subjects with anti-drug antibody (ADA) and neutralizing antibody (NAb) | Up to 1344 hours postdose |
| Change from baseline in numbers of neutrophils and monocytes | Up to 1344 hours postdose |
| Changes of granulocyte macrophage colony-stimulating factor (GM-CSF) receptor occupancy (RO) after the administration compared with the baseline | Up to 1344 hours postdose |