A Study of STSA-1002 Combined With STSA-1005 in Healthy Subjects

Healthy Subject Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05559125
• Other study ID #: STSA-1002/1005-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 8, 2022
• Est. completion date: August 2024

Study information

• Verified date: December 2023
• Source: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Contact: Min Liu
• Phone: +86 18519789088
• Email: liumin[@]staidson.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subject

Intervention

Drug:
• STSA-1002 Injection
Intravenous injection
• STSA-1005 Injection
Intravenous injection

Locations

Country	Name	City	State
China	The Second Affiliated Hospital Of Xingtai Medical College	Xingtai	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram?Vital Signs And Physical Examination Abnormalities.	To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects.	56 days
Secondary	Maximum plasma concentration (Cmax).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344hours postdose
Secondary	Area under the plasma concentration-time curve from time 0 to the collection time point t of the last measurable concentration (AUC0-t).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Area under the plasma concentration-time curve from time 0 to infinity (AUC0-8).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Time of maximum concentration (Tmax)	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344hours postdose
Secondary	Elimination half-life (t1/2).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Elimination rate constant (Kel).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Clearance (CL).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Apparent volume of distribution (Vz).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Mean residence time (MRTlast).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
Secondary	Extrapolated area under the curve (AUC_%Extrap).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344hours postdose
Secondary	Change from baseline in concentration of free C5a and anti-drug antibody.	To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 combined with STSA-1005 in healthy subjects.	Up to 1344 hours postdose
Secondary	Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-a, IFN-?, GM-CSF).	To evaluate the effects of STSA-1002 combined with STSA-1005 on cytokine (IL-2, IL-6, IL-8, IL-10, TNF-a, IFN-?, GM-CSF).	Up to 1344 hours postdose