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

NCT05000671 | Unknown Phase 1

• 1 other identifier: GPHIP-0103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

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).

Conditions

Acute Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (8)

• To evaluate the safety of STC314 injection in patients with ARDS.

  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.

  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.

  maximum concentration (Cmax)

  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)

  Through 0 to144 hours after the start of treatment

• To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.

  time to peak (Tmax)

  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)

  Through 0 to144 hours after the start of treatment

• To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.

  elimination rate constant(Kel)

  Through 0 to144 hours after the start of treatment

• To evaluate the pharmacokinetic of STC314 injection in patients with ARDS.

  clearance (CL)

  Through 0 to144 hours after the start of treatment

Secondary Outcomes (11)

• To evaluate the efficacy of STC314 injection in patients with ARDS.

  Within 28 days after the start of treatment

• To evaluate the efficacy of STC314 injection in patients with ARDS.

  Within 28 days after the start of treatment

• To evaluate the efficacy of STC314 injection in patients with ARDS.

  Within 28 days after the start of treatment

• To evaluate the efficacy of STC314 injection in patients with ARDS.

  Within 28 days after the start of treatment

• To evaluate the efficacy of STC314 injection in patients with ARDS.

  Within 28 days after the start of treatment

Other Outcomes (3)

• As an exploratory objective, the change in biomarkers from baseline following STC314 injection treatment in subjects with Acute Respiratory Distress Syndrome will be evaluated.

  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.

  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.

  Through 0 to144 hours after the start of treatment

Study Arms (2)

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)

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)

Drug: STC314 injection or Placebo(rate=87.5 mg/hr)

Interventions

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.

Cohort 1

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.

Cohort 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Grand Medical Pty Ltd.: lead
• Grand Pharmaceutical (China) Co., Ltd.: collaborator

Study Sites (5)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

NOT YET RECRUITING

Wuhan Jinyintan Hospital

Wuhan, Hubei, China

NOT YET RECRUITING

Wuhan Union Hospital

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

NOT YET RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

STC3141

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

James Pang, PhD

CONTACT

+61 466555916; jpang@grandpharma.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 11, 2021
• Study Start: July 28, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)