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

NCT05000671 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-12-27

No results posted yet for this study

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).

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

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.

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.

Sponsors & Collaborators

  • Grand Pharmaceutical (China) Co., Ltd.

    collaborator OTHER

  • Grand Medical Pty Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05000671 on ClinicalTrials.gov