A Study to Evaluate the Safety and Effect of STC314 Injection Continuous Infusion in Subjects With Acute Respiratory Distress Syndrome

December 23, 2021 updated by: Grand Medical Pty Ltd.

A Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Continuous Intravenous Infusion of STC314 Injection in Chinese Patients With Acute Respiratory Distress Syndrome

This study is a Randomized, Double-blinded, Placebo-controlled Phase Ib Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STC314 Injection Administered as Continuous Intravenous Infusion in Chinese Patients with ARDS (Acute Respiratory Distress Syndrome).

Study Overview

Status

Status

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

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 (Anticipated)

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.
16

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
      • Shijiazhuang, Hebei, China
        • Not yet recruiting
        • The fourth hospital of Hebei Medical University
        • Contact:
    • Hubei
      • Wuhan, Hubei, China
        • Not yet recruiting
        • Wuhan Jinyintan Hospital
        • Contact:
      • Wuhan, Hubei, China
    • Hunan
      • Changsha, Hunan, China
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda Hospital Southeast University
        • Contact:

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 ≤ age ≤ 70 years, male or female;
  2. Voluntarily participate in the study and sign the informed consent form;
  3. Diagnosis of ARDS for no more than 48 hours (starting at the time of diagnosis recorded in the medical record)；

  4. The following 2012 Berlin definition criteria for mild to moderate ARDS were met:

    1. From known clinical impairment and new or worsening of respiratory symptoms to fulfillment of diagnostic criteria is less than 7 days(inclusive).
    2. Chest imaging suggests bilateral infiltrates. The effusion, lobar/atelectasis, or nodules cannot completely explain the phenomenon.
    3. Respiratory failure cannot be completely explained by heart failure or fluid overload;
    4. When PEEP or CPAP ≥5 cm H2O, 100 mmHg≤PaO2/FiO2≤300 mmHg;
  5. Male subjects agree to use an effective contraceptive method from the start of the study until 7 days after the end of treatment; Female subjects of childbearing age agree to use an effective contraceptive method from the start of the study until 3 months after the end of treatment.

Exclusion Criteria:

  1. Positive serum pregnancy test before dosing for women of childbearing potential, pregnant women, or lactating women;
  2. Terminal phase of chronic disease with an expected survival of no more than 6 months;

  3. Combined with one of the following chronic organ damage or immunosuppressive diseases:

    1. Heart: New York Heart Association functional class IV;
    2. Lung: severe lung disease, including pulmonary hypertension, oxygen therapy or ventilator dependence for more than one month cumulatively within the first six months of screening, end-stage lung disease, or severe exercise limitation caused by chest wall malformations;
    3. Kidney: ongoing long-term dialysis treatment;
    4. Liver: biopsy confirmed cirrhosis and portal hypertension, or previous upper gastrointestinal bleeding caused by portal hypertension; Liver failure, hepatic encephalopathy, or hepatic coma;
    5. Immunosuppression: with lymphoma, leukemia or acquired immunodeficiency; Received anti-tumor chemotherapy in the last 3 months, or ongoing immunosuppressive therapy due to organ transplantation, immune diseases, etc.; Has undergone allogeneic bone marrow transplantation or hematopoietic stem cell transplantation; Steroid hormone therapy in the last 3 months (equivalent to > 0.5 mg/kg/day prednisone continued 1 month);

  4. History of one of the following within 4 weeks prior to screening:

    1. Acute pulmonary embolism;
    2. Cardiac arrest;
    3. Acute myocardial infarction;
  5. eGFR < 60 mL/min/BSA (calculated using CG formula);
  6. ALT > 5 x ULN, or total bilirubin > 2 x ULN;
  7. Severe anemia (hemoglobin < 7.0 g/dL);
  8. Absolute neutrophil count < 1500/μL;
  9. Platelet count < 50,000/μL;
  10. aPTT > 1.5 × ULN;
  11. Active bleeding that cannot be effectively controlled;
  12. The subject required therapeutic doses of heparin or was taking anticoagulants;
  13. ARDS caused by direct lung injury due to physical or chemical causes;
  14. Severe or greater burns: the overall surface area of burns exceeds 30% or the III degree burn area exceeds 10%; or the total area is less than 30%, but the general condition is severe or has shock, combined injury, respiratory tract burn;
  15. Allergic to the active ingredients or excipients of the study drug;
  16. Subjects have participated in other clinical studies (other than those who have not received intervention) or are participating in other experimental treatments within 1 month prior to screening;
  17. In the opinion of the investigator, the subject could not benefit from the study or was not suitable for participation 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: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

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
Drug: STC314/Placebo injection Continuous infusion at rate 58.3mg/hr up to 3 days (72 hours) N=8(Randomization-STC314/Placebo injection=3:1)
Drug: STC314 injection or Placebo(rate=58.3 mg/hr)
To receive continuous infusion of STC314/Placebo injection at rate 58.3mg/hr up to 3 days (72hours). Also to receive appropriate standard of care.
Experimental: Cohort 2
Drug: STC314/Placebo injection Continuous infusion at rate 87.5mg/hr up to 3 days (72 hours) N=8(Randomization-STC314/Placebo injection=3:1)
Drug: STC314 injection or Placebo(rate=87.5 mg/hr)
To receive continuous infusion of STC314/Placebo injection at rate 87.5mg/hr up to 3 days (72hours). Also to receive appropriate standard of care.

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
To evaluate the safety of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
The incidence of adverse event (AE) and serious adverse event (SAE);
Within 28 days after the start of treatment
To evaluate the safety of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Rates of Treatment Discontinuation Due to Adverse Events;
Within 28 days after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time Frame: Through 0 to144 hours after the start of treatment
maximum concentration (Cmax)
Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time Frame: Through 0 to144 hours after the start of treatment
area under the plasma concentration-time curve (AUC0-t, AUC0-inf)
Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time Frame: Through 0 to144 hours after the start of treatment
time to peak (Tmax)
Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time Frame: Through 0 to144 hours after the start of treatment
elimination half Decay (t1/2)
Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time Frame: Through 0 to144 hours after the start of treatment
elimination rate constant(Kel)
Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time Frame: Through 0 to144 hours after the start of treatment
clearance (CL)
Through 0 to144 hours after the start of treatment

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
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Changes of the value of blood lactate from baseline after dosing
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Change of Oxygenation Index (PaO2/FiO2) from baseline after dosing
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Change of Murray Lung Injury Score from baseline.(range 0-4, higher score means more severe lung injury)
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Change of the value of serum creatinine from baseline after dosing
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Change of the value of bilirubin from baseline after dosing
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Change of the value of Alanine Transaminase(ALT) from baseline after dosing
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Change of Sequential Organ Failure Assessment score from baseline after dosing.(range 0-4, higher score means a worse prognosis)
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
all-cause mortality within 28 days
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Ventilator-free survival time within 28 days
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
Hospitalization time within 28 days
Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time Frame: Within 28 days after the start of treatment
length of ICU stay within 28 days
Within 28 days after the start of treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated.
Time Frame: Through 0 to144 hours after the start of treatment
Change of the level of Histone in plasma after dosing
Through 0 to144 hours after the start of treatment
As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated.
Time Frame: Through 0 to144 hours after the start of treatment
Change of the level of Neutrophil extracellular traps(NETs)-related variables in plasma after dosing [myelinated Oxidase (MPO), citrullinated histone H3 (CitH3), circular free DNA (cfDNA)]
Through 0 to144 hours after the start of treatment
As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated.
Time Frame: Through 0 to144 hours after the start of treatment
Change of the level of inflammatory factor interleukin-6 (IL-6) after dosing
Through 0 to144 hours after the start of treatment

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.
Grand Medical Pty Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Grand Pharmaceutical (China) 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.
July 28, 2021

Primary Completion (Anticipated)

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.
December 1, 2022

Study Completion (Anticipated)

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.
December 1, 2022

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).
July 27, 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.
August 3, 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.
August 11, 2021

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.
December 27, 2021

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 23, 2021

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, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • GPHIP-0103

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

product manufactured in and exported from the U.S.

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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