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

Phase 1

Terminated

• Conditions: Healthy Subject
• Interventions: Drug: STSA-1002 Injection; Drug: STSA-1005 Injection

• Registration Number: NCT05559125
• Lead Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Study Start: 2022-11-08
• Status Verified: 2023-12
• Primary Completion: 2024-03-26
• Study Completion: 2024-03-26
• Last Update Submitted: 2024-05-20
• Last Update Posted: 2024-05-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
STSA-1002 and STSA-1005 dose level 3	STSA-1005 Injection	-
STSA-1002 and STSA-1005 dose level 4	STSA-1002 Injection	-
STSA-1002 and STSA-1005 dose level 1	STSA-1002 Injection	-
STSA-1002 and STSA-1005 dose level 2	STSA-1002 Injection	-
STSA-1002 and STSA-1005 dose level 2	STSA-1005 Injection	-
STSA-1002 and STSA-1005 dose level 3	STSA-1002 Injection	-
STSA-1002 and STSA-1005 dose level 4	STSA-1005 Injection	-
STSA-1002 and STSA-1005 dose level 1	STSA-1005 Injection	-

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram、Vital Signs And Physical Examination Abnormalities.	56 days	To evaluate the safety and tolerability of single intravenous administration of STSA-1002 combined with STSA-1005 in healthy adult subjects.

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax).	Up to 1344hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 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).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Elimination rate constant (Kel).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
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	To evaluate the effects of STSA-1002 combined with STSA-1005 on cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF).
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Apparent volume of distribution (Vz).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Mean residence time (MRTlast).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Extrapolated area under the curve (AUC_%Extrap).	Up to 1344hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Change from baseline in concentration of free C5a and anti-drug antibody.	Up to 1344 hours postdose	To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 combined with STSA-1005 in healthy subjects.
Time of maximum concentration (Tmax)	Up to 1344hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Elimination half-life (t1/2).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.
Clearance (CL).	Up to 1344 hours postdose	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.

Trial Locations

Locations (1)

The Second Affiliated Hospital Of Xingtai Medical College; 🇨🇳 Xingtai, Hebei, China