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

Grand Medical Pty Ltd.5 sites in 1 country16 target enrollmentJuly 28, 2021

ConditionsAcute Respiratory Distress Syndrome

InterventionsSTC314 injection or Placebo(rate=58.3 mg/hr)STC314 injection or Placebo(rate=87.5 mg/hr)

DrugsSTC314 injection or Placebo(rate=58.3 mg/hr)STC314 injection or Placebo(rate=87.5 mg/hr)

Overview

Phase: Phase 1
Intervention: STC314 injection or Placebo(rate=58.3 mg/hr)
Conditions: Acute Respiratory Distress Syndrome
Sponsor: Grand Medical Pty Ltd.
Enrollment: 16
Locations: 5
Primary Endpoint: To evaluate the safety of STC314 injection in patients with ARDS.
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

July 28, 2021

End Date

December 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Grand Medical Pty Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•18 ≤ age ≤ 70 years, male or female;
•Voluntarily participate in the study and sign the informed consent form;
•Diagnosis of ARDS for no more than 48 hours (starting at the time of diagnosis recorded in the medical record)；
•The following 2012 Berlin definition criteria for mild to moderate ARDS were met:
•From known clinical impairment and new or worsening of respiratory symptoms to fulfillment of diagnostic criteria is less than 7 days(inclusive).
•Chest imaging suggests bilateral infiltrates. The effusion, lobar/atelectasis, or nodules cannot completely explain the phenomenon.
•Respiratory failure cannot be completely explained by heart failure or fluid overload;
•When PEEP or CPAP ≥5 cm H2O, 100 mmHg≤PaO2/FiO2≤300 mmHg;
•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

•Positive serum pregnancy test before dosing for women of childbearing potential, pregnant women, or lactating women;
•Terminal phase of chronic disease with an expected survival of no more than 6 months;
•Combined with one of the following chronic organ damage or immunosuppressive diseases:
•Heart: New York Heart Association functional class IV;
•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;
•Kidney: ongoing long-term dialysis treatment;
•Liver: biopsy confirmed cirrhosis and portal hypertension, or previous upper gastrointestinal bleeding caused by portal hypertension; Liver failure, hepatic encephalopathy, or hepatic coma;
•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);
•History of one of the following within 4 weeks prior to screening:
•Acute pulmonary embolism;