The Safety of STSA-1002 Following Intravenous Infusion in Healthy Subjects

December 19, 2023 updated by: Staidson (Beijing) Biopharmaceuticals Co., Ltd

A Randomized, Double-blind, Placebo-controlled, Single-ascending Dose Phase Ⅰa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of STSA-1002Following Intravenous Infusion in Healthy Subjects

A randomized, double-blind, placebo-controlled, single-ascending dose Phase Ⅰa study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of STSA-1002 following intravenous infusion in healthy subjects

Study Overview

Status

Status

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

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.
52

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
    • Anhui
      • Hefei, Anhui, China, 230601
        • The Second Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 102600
        • Peking University People's Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510799
        • The fifth affiliated hosipital of Guangzhou medical university
      • Shenzhen, Guangdong, China, 518036
        • Peking University Shenzhen Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550004
        • The Affiliated Hospital of Guizhou Medical University

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy subjects, aged ≥ 18 but ≤ 65, male and female;
  • Body mass index: 18.0 -25.0 kg/m2, inclusive;
  • Subjects (including their partners) agree to take highly effective contraceptive measures during the study, and they have no birth plan or sperm donation plan within 5 months after the end of the study;
  • Medical histories, physical examinations, laboratory examinations and study-related examinations and tests of the subjects show normal results or mild abnormalities with no clinical significance before enrollment, and the Investigator judges that they are eligible;
  • Subjects are aware of the risks of the study, and voluntarily participate in the clinical study and sign an informed consent form (ICF).

Exclusion Criteria:

  • Past history of tuberculosis, history of contact with active tuberculosis, and positive tuberculin test results;
  • History of cardiovascular, respiratory, kidney, liver, metabolism, endocrine, gastrointestinal, blood, nerve, skin and mental illness, cancer or other major disease that in the judgment of the Investigator might put the subject as risk on this study;
  • There is a clear history of food or drug allergy or the total serum immunoglobulin IgE is higher than the upper limit of normal;
  • Positive screening test results for human immunodeficiency virus (HIV-1/HIV-2) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCVAb);
  • Presence of clinically significant vital signs values or of electrocardiogram (ECG) abnormalities during the screening period, as defined by an Investigator;
  • ANA positive;
  • During the screening period, the white blood cell count and C-reactive protein test results are abnormal and have clinical significance, hemoglobin: male <120g/L or female <110g/L;
  • Smoking more than 5 cigarettes per day or equivalent amount of tobacco in the 3 months before screening;
  • Subjects whose daily consumption of alcohol at the time of screening or at any time within the prior 6 months is more than 2 standard drinks, where 1 standard drink = 355 mL or 12 oz (1 can) of regular-strength (5%) beer; 150 mL or 5 oz wine; 45 mL or 1.5 oz liquor/spirits (40%);
  • Subjects who had a history of drug abuse or tested positive for drugs within 1 year before screening;
  • Subjects who have donated either more than approximately 500 mL of blood (exclusive plasma donation) within 3 mooth prior to screening or any plasma within 4 weeks prior to screening;
  • Participate in any drug or vaccine clinical trial as a subject within 3 months before screening or prepare to be vaccinated during the study period to 2 months after the end of the study;
  • Have taken drugs that may affect immune function within 6 months before screening or have received any monoclonal antibody or biological agent treatment within the previous 3 months and have taken prescription/over-the-counter drugs, herbal medicines, vitamins or other supplements within the previous 14 days;
  • Drink more than 5 cups of coffee, tea or cola per day (150ml and above per cup);
  • Women who are pregnant or breastfeeding;
  • People with a history of fainting, bleeding and needles;
  • The investigator believes that there are any subjects who are not suitable to participate in this trial.

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: Randomized
  • Interventional Model: Parallel 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: Cohort 1:2mg/kg
All participants (fasted) received either 2 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Drug: Placebo
Intravenous injection
Drug: STSA-1002 injection
Intravenous injection
Experimental: Cohort 2:5mg/kg
All participants (fasted) received either 5 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Drug: Placebo
Intravenous injection
Drug: STSA-1002 injection
Intravenous injection
Experimental: Cohort 3:10mg/kg
All participants (fasted) received either 10 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Drug: Placebo
Intravenous injection
Drug: STSA-1002 injection
Intravenous injection
Experimental: Cohort 4:20mg/kg
All participants (fasted) received either 20 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Drug: Placebo
Intravenous injection
Drug: STSA-1002 injection
Intravenous injection
Experimental: Cohort 5:30mg/kg
All participants (fasted) received either 30 mg/kg of STSA-1002 as a single dose or dose-matched placebo.
Drug: Placebo
Intravenous injection
Drug: STSA-1002 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 Abnormalities, Clinically Significant Vital Signs Abnormalities And Clinically Significant Physical Examination Abnormalities.
Time Frame: 48 days
48 days
Maximum plasma concentration (Cmax)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours 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 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Time of maximum concentration (Tmax)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Elimination half-life (t1/2)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Elimination rate constant of plasma drug concentration in terminal phase (λz)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Last measurable concentration (Clast)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Mean residence time (MRT)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Clearance (CL)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose
Apparent volume of distribution (Vz)
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacokinetics (PK) characteristics of STSA-1002 in healthy adult subjects
Up to 1152 hours postdose

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
Change from baseline in concentration of free C5a and anti-drug antibody
Time Frame: Up to 1152 hours postdose
To evaluate the pharmacodynamics (PD) characteristics and immunogenicity of STSA-1002 in healthy subjects
Up to 1152 hours postdose
Change from baseline in concentration of CH50, IL-6, IL-8,C4, TNF-α, IFN-γ
Time Frame: Up to 1152 hours postdose
To evaluate the effect of STSA-1002 on CH50, IL-6, IL-8, C4,TNF-α, IFN-γ
Up to 1152 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

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.
January 10, 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.
January 12, 2023

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.
January 12, 2023

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).
December 8, 2021

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.
December 8, 2021

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.
December 22, 2021

Study Record Updates

Last Update Posted (Estimated)

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.
December 20, 2023

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.
December 19, 2023

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.
April 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-1002-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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