Clinical trial NCT05559125: A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects
Official title: An Open-label, Single-ascending Dose Phase I Study to Evaluate the Safety and Tolerability of STSA-1002 Combined With STSA-1005 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Subject
Lead sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-09-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: An open-label, single-ascending dose phase I study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 combined with STSA-1005 in healthy subjects.


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;
* 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;
* The subjects were aware of the risks of the trial, voluntarily participated in the study and signed the informed consent form (ICF).

Exclusion Criteria:

* Have a history of serious disease (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric or cardiovascular diseases) or have undergone any major surgery within 2 months prior to screening;
* The investigators determined that abnormalities in pre-enrollment physical examinations, laboratory tests, and trial-related tests were clinically significant;
* A definite history of food or drug allergies;
* Positive screening test results for human immunodeficiency virus (HIV) antibodies, syphilis-specific antibody, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
* History of tuberculosis; or combined with T-SPOT.TB results, low-dose chest CT comprehensive evaluation of tuberculosis infection;
* Hemoglobin was lower than the lower limit of normal value during the screening period;
* Smoking more than 5 or equivalent cigarettes per day in the 3 months before screening;
* Regular drinkers in the 6 months prior to screening, i.e. those who have consumed more than 2 units of alcohol per day (1 unit =360ml beer or 45ml spirits with an alcohol concentration of 40% or 150ml wine) in the 6 months prior to screening or have a positive alcohol test result;
* Subjects with a history of substance abuse within 1 year before screening or have a positive drug test result;
* Blood loss or blood donation \> 400ml three months before screening, or blood transfusion history within 4 weeks before inclusion;
* Participate in clinical trials of new drugs or vaccines as a subject within 3 months prior to screening；
* Vaccination was given within 1 month before screening or planned between the study period and 2 months after the end of the study;
* Use of medications that may affect immune function in the 6 months prior to screening or any monoclonal antibody or biologic treatment in the 3 months prior to screening and use of prescription drugs/over-the-counter drugs or herbal medicines in the 14 days prior to screening；
* Drink more than 5 cups of coffee, tea or cola (150ml or more per cup) daily within 3 months before screening;
* Pregnant or lactating women;
* A history of blood and needle sickness；
* Other circumstances in which the investigator considers it inappropriate to participate in the study.

Primary outcomes:
measure: Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
timeFrame: 56 days
Secondary outcomes:
measure: Maximum plasma concentration (Cmax).
timeFrame: Up to 1344hours postdose
measure: Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t).
timeFrame: Up to 1344 hours postdose
measure: Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).
timeFrame: Up to 1344 hours postdose
measure: Time of maximum concentration (Tmax)
timeFrame: Up to 1344hours postdose
measure: Elimination half-life (t1/2).
timeFrame: Up to 1344 hours postdose
measure: Elimination rate constant (Kel).
timeFrame: Up to 1344 hours postdose
measure: Clearance (CL).
timeFrame: Up to 1344 hours postdose
measure: Apparent volume of distribution (Vz).
timeFrame: Up to 1344 hours postdose
measure: Mean residence time (MRTlast).
timeFrame: Up to 1344 hours postdose
measure: Extrapolated area under the curve (AUC_%Extrap).
timeFrame: Up to 1344hours postdose
measure: Change from baseline in concentration of free C5a and anti-drug antibody.
timeFrame: Up to 1344 hours postdose
measure: Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF).
timeFrame: Up to 1344 hours postdose
Other outcomes:
Locations:
city: Xingtai
country: China
facility: The Second Affiliated Hospital Of Xingtai Medical College
state: Hebei
Study officials:
affiliation: The Second Affiliated Hospital of Xingtai Medical College
name: Fengxue Guo, Bachelor
role: PRINCIPAL_INVESTIGATOR
References: