Acute Respiratory Distress SyndromePhase 1NCT05000671
A Study to Evaluate the Safety and Effect of STC314 Injection Continuous Infusion in Subjects With Acute Respiratory Distress Syndrome
A Phase 1 study of Acute Respiratory Distress Syndrome, run by Grand Medical Pty Ltd. at 5 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 5 sitesChina
- Study dates
- 28 Jul 2021to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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;
Show all 25Show fewer
- 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;
- Cardiac arrest;
- Acute myocardial infarction;
- eGFR < 60 mL/min/BSA (calculated using CG formula);
- ALT > 5 x ULN, or total bilirubin > 2 x ULN;
- Severe anemia (hemoglobin < 7.0 g/dL);
- Absolute neutrophil count < 1500/μL;
- Platelet count < 50,000/μL;
- aPTT > 1.5 × ULN;
- Active bleeding that cannot be effectively controlled;
- The subject required therapeutic doses of heparin or was taking anticoagulants;
- ARDS caused by direct lung injury due to physical or chemical causes;
- 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;
- Allergic to the active ingredients or excipients of the study drug;
- 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;
- In the opinion of the investigator, the subject could not benefit from the study or was not suitable for participation in the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Pinhua Pan, MD, pinhuapan668@126.com
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu
Haibo Qiu, MD, haiboq2000@gmail.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zhenjie Hu, MD, syicu@vip.sina.com
- Not yet recruiting
Wuhan Jinyintan Hospital
Wuhan, Hubei
Wenjuan Wu, MD, 1346801465@qq.com
- Recruiting
Wuhan Union Hospital
Wuhan, Hubei
Shiying Yuan, MD, yuan_shiying@163.com
About this study
Official title: 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).
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- STC314 injection or Placebo(rate=58.3 mg/hr), STC314 injection or Placebo(rate=87.5 mg/hr)
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STC314 injection or Placebo(rate=58.3 mg/hr)Drug
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.
STC314 injection or Placebo(rate=87.5 mg/hr)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 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) Receives: Drug: STC314 injection or Placebo(rate=58.3 mg/hr) |
| Cohort 2 | Experimental | 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) Receives: Drug: STC314 injection or Placebo(rate=87.5 mg/hr) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of STC314 injection in patients with ARDS.
The incidence of adverse event (AE) and serious adverse event (SAE);
Measured: Within 28 days after the start of treatment
To evaluate the safety of STC314 injection in patients with ARDS.
Rates of Treatment Discontinuation Due to Adverse Events;
Measured: Within 28 days after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
maximum concentration (Cmax)
Measured: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
area under the plasma concentration-time curve (AUC0-t, AUC0-inf)
Measured: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
time to peak (Tmax)
Measured: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
elimination half Decay (t1/2)
Measured: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
elimination rate constant(Kel)
Measured: Through 0 to144 hours after the start of treatment
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
clearance (CL)
Measured: Through 0 to144 hours after the start of treatment
Secondary outcomes (11)
To evaluate the efficacy of STC314 injection in patients with ARDS.
Changes of the value of blood lactate from baseline after dosing
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of Oxygenation Index (PaO2/FiO2) from baseline after dosing
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of Murray Lung Injury Score from baseline.(range 0-4, higher score means more severe lung injury)
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of the value of serum creatinine from baseline after dosing
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of the value of bilirubin from baseline after dosing
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of the value of Alanine Transaminase(ALT) from baseline after dosing
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Change of Sequential Organ Failure Assessment score from baseline after dosing.(range 0-4, higher score means a worse prognosis)
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
all-cause mortality within 28 days
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Ventilator-free survival time within 28 days
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
Hospitalization time within 28 days
Measured: Within 28 days after the start of treatment
To evaluate the efficacy of STC314 injection in patients with ARDS.
length of ICU stay within 28 days
Measured: Within 28 days after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start28 Jul 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grand Medical Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000671
- Sponsor's protocol ID
- GPHIP-0103
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05000671
- Acronym / sponsor ID
- GPHIP-0103
- Conditions
- Acute Respiratory Distress Syndrome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Grand Medical Pty Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Grand Pharmaceutical (China) Co., Ltd.
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: STC314 injection or Placebo(rate=58.3 mg/hr)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) |
| Cohort 2 | Experimental | Drug: STC314 injection or Placebo(rate=87.5 mg/hr)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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (25 listed)
- 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:
- History of one of the following within 4 weeks prior to screening:
- eGFR < 60 mL/min/BSA (calculated using CG formula);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Cohort 1 |
| 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. | Drug | Cohort 2 |
Primary outcome
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)
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)
To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.
Time frame: Through 0 to144 hours after the start of treatment
clearance (CL)
11 secondary outcomes
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time frame: 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
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time frame: 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
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time frame: 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
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time frame: 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
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time frame: 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
To evaluate the efficacy of STC314 injection in patients with ARDS.
Time frame: Within 28 days after the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Distress Syndrome
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruitingObservational study
Development and Multicenter Validation of an Explainable System for Neonatal ARDS-Compatible Phenotyping
Acute Respiratory Distress Syndrome
RecruitingObservational study
Assessment of Blood Viscosity in ARDS (Acute Respiratory Distress Syndrome)
ARDS
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Acute Respiratory Distress Syndrome, run by Grand Medical Pty Ltd. at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James Pang, PhD (+61 466555916, jpang@grandpharma.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of STC314 injection in patients with ARDS. (time frame: Within 28 days after the start of treatment). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.