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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Subject
• Intervention / Treatment: Drug: STSA-1002 Injection; Drug: STSA-1005 Injection

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Min Liu; Phone Number: +86 18519789088; Email: liumin@staidson.com

Study Locations

• China
  • Hebei
    • Xingtai, Hebei, China, 054000
      • Recruiting
      • The Second Affiliated Hospital of Xingtai Medical College
      • Contact: Fengxue Guo; Phone Number: 0319-2279896; Email: gfx0266@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: STSA-1002 and STSA-1005 dose level 1	Drug: STSA-1002 Injection; Intravenous injection; Drug: STSA-1005 Injection; Intravenous injection
Experimental: STSA-1002 and STSA-1005 dose level 2	Drug: STSA-1002 Injection; Intravenous injection; Drug: STSA-1005 Injection; Intravenous injection
Experimental: STSA-1002 and STSA-1005 dose level 3	Drug: STSA-1002 Injection; Intravenous injection; Drug: STSA-1005 Injection; Intravenous injection
Experimental: STSA-1002 and STSA-1005 dose level 4	Drug: STSA-1002 Injection; Intravenous injection; Drug: STSA-1005 Injection; Intravenous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞).	To evaluate the single dose pharmacokinetics (PK) characteristics of STSA-1002 combined with STSA-1005 in healthy adult subjects.	Up to 1344 hours postdose
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
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
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
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
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
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
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
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
Change from baseline in concentration of cytokine (IL-2, IL-6, IL-8, IL-10, TNF-α, IFN-γ, GM-CSF).	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).	Up to 1344 hours postdose

Collaborators and Investigators

• Sponsor: Staidson (Beijing) Biopharmaceuticals Co., Ltd
• Investigators: Principal Investigator: Fengxue Guo, Bachelor, The Second Affiliated Hospital of Xingtai Medical College

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 26, 2022
• First Posted (Actual): September 29, 2022

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: STSA-1002/1005-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No