Who is sponsoring NCT05000671?

NCT05000671 is sponsored by Grand Medical Pty Ltd..

What drugs are being tested in NCT05000671?

Interventions in NCT05000671: STC314 injection or Placebo(rate=58.3 mg/hr), STC314 injection or Placebo(rate=87.5 mg/hr).

What condition does NCT05000671 study?

NCT05000671 studies Acute Respiratory Distress Syndrome.

Is NCT05000671 still recruiting?

NCT05000671 is currently status unknown. Last updated 23 December 2021.

Last reviewed 2021-12-23 · How we verify

NCT05000671

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 23 December 2021

What this trial tests

Phase 1 trial testing STC314 injection or Placebo(rate=58.3 mg/hr) in Acute Respiratory Distress Syndrome in 16 participants. Status unknown.

Timeline

28 July 2021

Primary endpoint
1 December 2022

1 December 2022

Quick facts

Lead sponsor	Grand Medical Pty Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	16
Start date	28 July 2021
Primary completion	1 December 2022
Estimated completion	1 December 2022
Sites	5 locations across China

Drugs / interventions tested

STC314 injection or Placebo(rate=58.3 mg/hr) — full drug profile →
STC314 injection or Placebo(rate=87.5 mg/hr) — full drug profile →

Conditions studied

Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →

Sponsor

Grand Medical Pty Ltd. — full company profile →

Who can join

Adults 18 to 70, any sex, with Acute Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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);
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;
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)
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)
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)
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)

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Acute Respiratory Distress Syndrome

Currently open trials in the same condition.

NCT07284888 — Practices of Prone Positioning Ventilation in Patients With Moderate-to-Severe ARDS in Intensive Care Units: A Registry- · recruiting
NCT07289711 — Validation and Precision Treatment of Inflammatory Subphenotypes in Acute Respiratory Distress Syndrome: A Multicenter C · recruiting
NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
NCT06919484 — The Physiological Effect of RCexp on Ventilation/Perfusion Distribution · recruiting
NCT07126964 — Extended Prone Positioning for Intubated ARDS · NA · recruiting

Other Grand Medical Pty Ltd. trials

Trials by the same sponsor.

NCT06548854 — A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploration Clinical Trial Evaluating the Effi · Phase 2 · active not recruiting
NCT04880694 — A Study to Evaluate the Safety and Effect of STC3141 Continuous Infusion in Subjects With Severe Corona Virus Disease 20 · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05000671 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grand Medical Pty Ltd.
Last refreshed: 23 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05000671.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing