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

May 20, 2024 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Hebei
      • Xingtai, Hebei, China, 054000
        • The Second Affiliated Hospital of Xingtai Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
56 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax).
Time Frame: Up to 1344hours postdose
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).
Time Frame: Up to 1344 hours postdose
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-∞).
Time Frame: Up to 1344 hours postdose
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)
Time Frame: Up to 1344hours postdose
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).
Time Frame: Up to 1344 hours postdose
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).
Time Frame: Up to 1344 hours postdose
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).
Time Frame: Up to 1344 hours postdose
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).
Time Frame: Up to 1344 hours postdose
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).
Time Frame: Up to 1344 hours postdose
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).
Time Frame: Up to 1344hours postdose
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.
Time Frame: Up to 1344 hours postdose
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).
Time Frame: 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).
Up to 1344 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Staidson (Beijing) Biopharmaceuticals Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fengxue Guo, Bachelor, The Second Affiliated Hospital of Xingtai Medical College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 26, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 26, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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