Clinical Trials/NCT05559125

NCT05559125

Terminated

Phase 1

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

Staidson (Beijing) Biopharmaceuticals Co., Ltd1 site in 1 country50 target enrollmentNovember 8, 2022

ConditionsHealthy Subject

InterventionsSTSA-1002 Injection STSA-1005 Injection

DrugsSTSA-1002 Injection STSA-1005 Injection

Overview

Phase: Phase 1
Intervention: STSA-1002 Injection
Conditions: Healthy Subject
Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
Enrollment: 50
Locations: 1
Primary Endpoint: Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 8, 2022

End Date

March 26, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Staidson (Beijing) Biopharmaceuticals Co., Ltd

Responsible Party

Sponsor

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;

Arms & Interventions

STSA-1002 and STSA-1005 dose level 1

Intervention: STSA-1002 Injection

STSA-1002 and STSA-1005 dose level 1

Intervention: STSA-1005 Injection

STSA-1002 and STSA-1005 dose level 2

Intervention: STSA-1002 Injection

STSA-1002 and STSA-1005 dose level 2

Intervention: STSA-1005 Injection

STSA-1002 and STSA-1005 dose level 3

Intervention: STSA-1002 Injection

STSA-1002 and STSA-1005 dose level 3

Intervention: STSA-1005 Injection

STSA-1002 and STSA-1005 dose level 4

Intervention: STSA-1002 Injection

STSA-1002 and STSA-1005 dose level 4

Intervention: STSA-1005 Injection

Outcomes

Primary Outcomes

Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.

Time Frame: 56 days

To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects.

Secondary Outcomes

Maximum plasma concentration (Cmax).(Up to 1344hours postdose)
Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t).(Up to 1344 hours postdose)
Elimination rate constant (Kel).(Up to 1344 hours postdose)
Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF).(Up to 1344 hours postdose)
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).(Up to 1344 hours postdose)
Apparent volume of distribution (Vz).(Up to 1344 hours postdose)
Mean residence time (MRTlast).(Up to 1344 hours postdose)
Extrapolated area under the curve (AUC_%Extrap).(Up to 1344hours postdose)
Change from baseline in concentration of free C5a and anti-drug antibody.(Up to 1344 hours postdose)
Time of maximum concentration (Tmax)(Up to 1344hours postdose)
Elimination half-life (t1/2).(Up to 1344 hours postdose)
Clearance (CL).(Up to 1344 hours postdose)