ARDS (Acute Respiratory Distress Syndrome)Phase 1/2NCT07706855
Safety and Efficacy Study of GKL-006RTU in Moderate to Severe Acute Respiratory Distress Syndrome (ARDS)
A Phase 1/2 study testing GKL-006RTU injection in people with ARDS (Acute Respiratory Distress Syndrome), run by Beijing Gene Key Life Technology Co., Ltd.
Trial summary
This is a Phase I/II, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of GKL-006RTU injection in participants with moderate to severe Acute Respiratory Distress Syndrome (ARDS). The study consists of two parts: Phase I is a single-arm, open-label study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ARDS (Acute Respiratory Distress Syndrome)
- What is being tested?
- GKL-006RTU injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 10 Nov 2026to 30 May 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 80 years (inclusive).
- Participants (or their legally authorized representatives, if the participant is unable to provide informed consent) who fully understand the nature of the study, voluntarily sign the informed consent form, and are willing to comply with and complete all study procedures during the study period.
- Clinically diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to the diagnostic criteria, with a time from diagnosis to enrollment not exceeding 96 hours.
- The etiology of ARDS is confirmed to be infectious.
- Received active treatment (including anti-infective therapy and lung-protective ventilation strategies) for at least 24 hours; and arterial blood gas analysis results within 6 hours prior to enrollment support the diagnosis of moderate-to-severe ARDS (defined as Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) ≤ 200 mmHg and Positive End-Expiratory Pressure [PEEP] ≥ 5 cmH2O).
- Participants and their partners must have no plans for reproduction, sperm donation, or egg donation for at least 6 months after the last dose of study drug, and must voluntarily adopt effective contraceptive measures deemed appropriate by the investigator.
Who cannot join
- Positive screening for infectious diseases meeting any of the following: a)Active Hepatitis B virus infection (defined as [positive Hepatitis B Surface Antigen (HBsAg) or positive Hepatitis B Core Antibody (HBcAb)] with Hepatitis B Virus DNA [HBV-DNA] above the upper limit of normal); b) Hepatitis C virus (HCV) infection (defined as positive HCV antibody with HCV-RNA above the upper limit of normal); c) Human Immunodeficiency Virus (HIV) infection (defined as positive HIV antibody); d) Syphilis infection (defined as positive Treponema pallidum antibody).
- Known immune system dysfunction (e.g., primary immunodeficiency, acquired immunodeficiency) or currently receiving systemic immunosuppressive therapy.
- Expected survival time of less than 72 hours.
- Occurrence of a cerebrovascular or cardiovascular event (unstable angina, congestive heart failure, myocardial infarction, or stroke) within the past 6 months; or severe cardiovascular disease at screening: New York Heart Association (NYHA) Functional Classification Class III or higher; uncontrolled myocarditis or valvular disease; hemodynamic instability, severe cardiac dysfunction, malignant arrhythmias, or severe rhythm/conduction abnormalities requiring drug therapy within the past 6 months.
- Currently receiving or expected to receive Extracorporeal Membrane Oxygenation (ECMO) during the trial period.
- Severe hepatic or renal dysfunction at screening: long-term hemodialysis and known severe renal impairment with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² (calculation method detailed in Appendix 6), currently requiring Continuous Renal Replacement Therapy (CRRT); or moderate to severe liver failure (Child-Pugh score > 12 ).
Show all 17Show fewer
- Severe hematological abnormalities at screening: evidence of bleeding with an International Normalized Ratio (INR) ≥ 2.0; severe anemia (Hemoglobin [Hb] < 60 g/L); moderate or greater thrombocytopenia (Platelets [PLT] < 50×10⁹/L); Disseminated Intravascular Coagulation (DIC); leukemia; or other hematological abnormalities deemed unsuitable for enrollment.
- Severe end-stage respiratory diseases at screening (e.g., COPD with respiratory failure, pulmonary fibrosis, pulmonary hypertension with right heart failure, etc., excluding ARDS).
- History of deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment.
- History of solid organ or hematopoietic stem cell transplantation.
- Severe cardiopulmonary malformations at screening that significantly affect cardiopulmonary function.
- Severe neuropsychiatric disorders (e.g., Alzheimer's disease, schizophrenia).
- ARDS caused by other etiologies (e.g., trauma, aspiration).
- Pregnant or lactating women.
- Cumulative corticosteroid use equivalent to > 400 mg of prednisone within 3 weeks prior to screening.
- Known hypersensitivity to any component of the investigational product, or a history of severe allergies deemed unsuitable for enrollment by the investigator.
- Receipt of cell therapy within 6 months prior to screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GKL-006RTU Injection in Patients With Moderate to Severe Acute Respiratory Distress Syndrome
This is a Phase I/II, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of GKL-006RTU injection in participants with moderate to severe Acute Respiratory Distress Syndrome (ARDS).
The study consists of two parts:
Read more
Phase I is a single-arm, open-label study. Eligible participants will receive a single intravenous infusion of GKL-006RTU injection (1 bag or 3 bags, containing approximately 5.0±0.5×10^8 invariant natural killer T (iNKT) cells per bag) in addition to standard background treatment. The primary objective of this phase is to assess the safety and tolerability of the investigational product.
Phase II is a randomized, double-blind, placebo-controlled study. Based on the results from Phase I, participants will receive GKL-006RTU injection or placebo via intravenous infusion, in addition to standard background treatment. The primary objective of this phase is to evaluate the efficacy of GKL-006RTU injection in treating moderate to severe ARDS.
- Being tested
- GKL-006RTU injection, Placebo
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKL-006RTU injectionDrug
iNKT cell injection
PlaceboDrug
Matching placebo for GKL-006RTU injection
| Study group | Role | What they receive |
|---|---|---|
| Phase I: GKL-006RTU injection (1 or 3 Bags) | Experimental | A single-arm, open-label dose-escalation study. Dose Level 1: 1 bag of GKL-006RTU injection (25 mL/bag, containing 5.0±0.5×10^8 iNKT cells).
Dose Level 2: 3 bags of RTU injection (25 mL/bag, containing 5.0±0.5×10^8 iNKT cells per bag).
Dose escalation follows the '3+3' design based on dose-limiting toxicities (DLTs) observed within a 28-day safety window.
All participants will receive standard of care background therapy as per clinical guidelines, including restrictive fluid management and lung-protective ventilation strategies. Supportive care medications (for example, antibiotics, albumin, diuretics) and organ support will be administered at the investigator's discretion based on individual patient needs. Receives: Drug: GKL-006RTU injection |
| Phase II: GKL-006RTU Injection | Experimental | Participants in this arm will receive the Recommended Phase II Dose of GKL-006RTU injection . This is a randomized, double-blind portion of the study.
All participants will receive standard of care background therapy as per clinical guidelines, including restrictive fluid management and lung-protective ventilation strategies. Supportive care medications (for example, antibiotics, albumin, diuretics) and organ support will be administered at the investigator's discretion based on individual patient needs. Receives: Drug: GKL-006RTU injection |
| Phase II: Placebo | Placebo comparator | Participants in this arm will receive matching placebo. They will be randomized in a 1:1 ratio to the GKL-006RTU injection arm. The study is double-blind.
All participants will receive standard of care background therapy as per clinical guidelines, including restrictive fluid management and lung-protective ventilation strategies. Supportive care medications (for example, antibiotics, albumin, diuretics) and organ support will be administered at the investigator's discretion based on individual patient needs. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Incidence and Severity of Adverse Events and Serious Adverse Events
To evaluate the safety and tolerability of GKL-006RTU injection in participants with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). Safety will be assessed throughout the study duration, from Day 1 to Day 180.
Measured: Day 1 to Day 180
Phase II: Difference in Ventilator-Free Days within 28 Days Compared to Placebo
To evaluate the efficacy of GKL-006RTU injection compared to placebo in participants with moderate-to-severe ARDS. The primary efficacy endpoint is the difference in ventilator-free days (days alive and free from mechanical ventilation) within 28 days post-treatment between the GKL-006RTU injection group and the placebo group.
Measured: Day 1 to Day 28
Secondary outcomes (17)
Phase I: All-cause Mortality at Day 1 to Day 28, Day 90, and Day 180
To assess the all-cause mortality rate in participants treated with GKL-006RTU injection at Day 1 to Day 28, Day 90, and Day 180.
Measured: Day 1 to Day 28, Day 90, and Day 180
Phase I: Ventilator-Free Days, ICU-Free Days, and Organ Support-Free Days within Day 1 to Day 28
To evaluate the number of days alive and free from mechanical ventilation, intensive care unit (ICU) stay, and organ support from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase I: Change in Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) from Baseline
The ratio is calculated by dividing the arterial partial pressure of oxygen by the fraction of inspired oxygen. Measurements will be taken at baseline and various time points from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase I: Change in Arterial Potential of Hydrogen (pH) from Baseline
To evaluate the change in arterial pH from baseline at various time points from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase I: Change in Arterial Partial Pressure of Oxygen (PaO2) from Baseline
To evaluate the change in arterial partial pressure of oxygen (PaO2) from baseline at various time points from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase I: Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) from Baseline.
To evaluate the change in arterial partial pressure of carbon dioxide (PaCO2) from baseline at various time points from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase I: Change in Arterial Lactate from Baseline
To evaluate the change in arterial lactate levels from baseline at various time points from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase I: Change in Sequential Organ Failure Assessment (SOFA)-2 Score from Baseline
To evaluate the change in the Sequential Organ Failure Assessment (SOFA)-2 score from baseline. The SOFA-2 score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction/failure. Assessments will be made at various time points from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase II: Difference in All-cause Mortality Compared to Placebo at Day 7, Day 14, Day 28, Day 90, and Day 180
To evaluate the difference in all-cause mortality between the GKL-006RTU injection group and the placebo group at Day 7, Day 14, Day 28, Day 90, and Day 180.
Measured: Day 7, Day 14, Day 28, Day 90, and Day 180
Phase II: Difference in ICU-Free Days and Organ Support-Free Days Compared to Placebo within Day 1 to Day 28
To evaluate the difference in days free from intensive care unit (ICU) stay and days free from organ support between the GKL-006RTU injection group and the placebo group from Day 1 to Day 28.
Measured: Day 1 to Day 28
Phase II: Difference in Change of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) Compared to Placebo
To evaluate the difference in the change of the PaO2/FiO2 ratio from baseline between the GKL-006RTU injection group and the placebo group.
Measured: Day 1 to Day 28
Phase II: Difference in Change of Arterial Potential of Hydrogen (pH) Compared to Placebo.
To evaluate the difference in the change of arterial pH from baseline between the GKL-006RTU injection group and the placebo group.
Measured: Day 1 to Day 28
Phase II: Difference in Change of Arterial Partial Pressure of Oxygen (PaO2) Compared to Placebo.
To evaluate the difference in the change of arterial partial pressure of oxygen (PaO2) from baseline between the GKL-006RTU injection group and the placebo group.
Measured: Day 1 to Day 28
Phase II: Difference in Change of Arterial Partial Pressure of Carbon Dioxide (PaCO2) Compared to Placebo
To evaluate the difference in the change of arterial partial pressure of carbon dioxide (PaCO2) from baseline between the GKL-006RTU injection group and the placebo group.
Measured: Day 1 to Day 28
Title: Phase II: Difference in Change of Arterial Lactate Compared to Placebo
To evaluate the difference in the change of arterial lactate levels from baseline between the GKL-006RTU injection group and the placebo group.
Measured: Day 1 to Day 28
Phase II: Difference in Change of Sequential Organ Failure Assessment (SOFA)-2 Score Compared to Placebo
To evaluate the difference in the change of the Sequential Organ Failure Assessment (SOFA)-2 score from baseline between the GKL-006RTU injection group and the placebo group. The SOFA-2 score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction or failure.
Measured: Day 1 to Day 28
Phase II: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 to Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start10 Nov 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Acute Respiratory Distress Syndrome)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706855
- Sponsor's protocol ID
- GKL006RTUST01
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share individual participant data at this time.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of GKL-006RTU Injection in Patients With Moderate to Severe Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07706855
- Acronym / sponsor ID
- GKL006RTUST01
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Beijing Gene Key Life Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 May 2029 (estimated)
- First posted
- 16 Jul 2026 (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 is a Phase I/II, multicenter study designed to evaluate the safety, tolerability, and preliminary efficacy of GKL-006RTU injection in participants with moderate to severe Acute Respiratory Distress Syndrome (ARDS).
The study consists of two parts:
Phase I is a single-arm, open-label study. Eligible participants will receive a single intravenous infusion of GKL-006RTU injection (1 bag or 3 bags, containing approximately 5.0±0.5×10^8 invariant natural killer T (iNKT) cells per bag) in addition to standard background treatment. The primary objective of this phase is to assess the safety and tolerability of the investigational product.
Phase II is a randomized, double-blind, placebo-controlled study. Based on the results from Phase I, participants will receive GKL-006RTU injection or placebo via intravenous infusion, in addition to standard background treatment. The primary objective of this phase is to evaluate the efficacy of GKL-006RTU injection in treating moderate to severe ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase I: GKL-006RTU injection (1 or 3 Bags) | Experimental | Drug: GKL-006RTU injectionA single-arm, open-label dose-escalation study. Dose Level 1: 1 bag of GKL-006RTU injection (25 mL/bag, containing 5.0±0.5×10^8 iNKT cells). Dose Level 2: 3 bags of RTU injection (25 mL/bag, containing 5.0±0.5×10^8 iNKT cells per bag). Dose escalation follows the '3+3' design based on dose-limiting toxicities (DLTs) observed within a 28-day safety window. All participants will receive standard of care background therapy as per clinical guidelines, including restrictive fluid management and lung-protective ventilation strategies. Supportive care medications (for example, antibiotics, albumin, diuretics) and organ support will be administered at the investigator's discretion based on individual patient needs. |
| Phase II: GKL-006RTU Injection | Experimental | Drug: GKL-006RTU injectionParticipants in this arm will receive the Recommended Phase II Dose of GKL-006RTU injection . This is a randomized, double-blind portion of the study. All participants will receive standard of care background therapy as per clinical guidelines, including restrictive fluid management and lung-protective ventilation strategies. Supportive care medications (for example, antibiotics, albumin, diuretics) and organ support will be administered at the investigator's discretion based on individual patient needs. |
| Phase II: Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will receive matching placebo. They will be randomized in a 1:1 ratio to the GKL-006RTU injection arm. The study is double-blind. All participants will receive standard of care background therapy as per clinical guidelines, including restrictive fluid management and lung-protective ventilation strategies. Supportive care medications (for example, antibiotics, albumin, diuretics) and organ support will be administered at the investigator's discretion based on individual patient needs. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, aged 18 to 80 years (inclusive).
- Participants (or their legally authorized representatives, if the participant is unable to provide informed consent) who fully understand the nature of the study, voluntarily sign the informed consent form, and are willing to comply with and complete all study procedures during the study period.
- Clinically diagnosed with Acute Respiratory Distress Syndrome (ARDS) according to the diagnostic criteria, with a time from diagnosis to enrollment not exceeding 96 hours.
- The etiology of ARDS is confirmed to be infectious.
- Received active treatment (including anti-infective therapy and lung-protective ventilation strategies) for at least 24 hours; and arterial blood gas analysis results within 6 hours prior to enrollment support the diagnosis of moderate-to-severe ARDS (defined as Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) ≤ 200 mmHg and Positive End-Expiratory Pressure [PEEP] ≥ 5 cmH2O).
Key exclusion criteria (17 listed)
- Positive screening for infectious diseases meeting any of the following: a)Active Hepatitis B virus infection (defined as [positive Hepatitis B Surface Antigen (HBsAg) or positive Hepatitis B Core Antibody (HBcAb)] with Hepatitis B Virus DNA [HBV-DNA] above the upper limit of normal); b) Hepatitis C virus (HCV) infection (defined as positive HCV antibody with HCV-RNA above the upper limit of normal); c) Human Immunodeficiency Virus (HIV) infection (defined as positive HIV antibody); d) Syphilis infection (defined as positive Treponema pallidum antibody).
- Known immune system dysfunction (e.g., primary immunodeficiency, acquired immunodeficiency) or currently receiving systemic immunosuppressive therapy.
- Expected survival time of less than 72 hours.
- Occurrence of a cerebrovascular or cardiovascular event (unstable angina, congestive heart failure, myocardial infarction, or stroke) within the past 6 months; or severe cardiovascular disease at screening: New York Heart Association (NYHA) Functional Classification Class III or higher; uncontrolled myocarditis or valvular disease; hemodynamic instability, severe cardiac dysfunction, malignant arrhythmias, or severe rhythm/conduction abnormalities requiring drug therapy within the past 6 months.
- Currently receiving or expected to receive Extracorporeal Membrane Oxygenation (ECMO) during the trial period.
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 |
|---|---|---|
| GKL-006RTU injectioniNKT cell injection | Drug | Phase I: GKL-006RTU injection (1 or 3 Bags), Phase II: GKL-006RTU Injection |
| PlaceboMatching placebo for GKL-006RTU injection | Drug | Phase II: Placebo |
Primary outcome
Phase I: Incidence and Severity of Adverse Events and Serious Adverse Events
Time frame: Day 1 to Day 180
To evaluate the safety and tolerability of GKL-006RTU injection in participants with moderate-to-severe Acute Respiratory Distress Syndrome (ARDS). Safety will be assessed throughout the study duration, from Day 1 to Day 180.
Phase II: Difference in Ventilator-Free Days within 28 Days Compared to Placebo
Time frame: Day 1 to Day 28
To evaluate the efficacy of GKL-006RTU injection compared to placebo in participants with moderate-to-severe ARDS. The primary efficacy endpoint is the difference in ventilator-free days (days alive and free from mechanical ventilation) within 28 days post-treatment between the GKL-006RTU injection group and the placebo group.
17 secondary outcomes
Phase I: All-cause Mortality at Day 1 to Day 28, Day 90, and Day 180
Time frame: Day 1 to Day 28, Day 90, and Day 180
Phase I: Ventilator-Free Days, ICU-Free Days, and Organ Support-Free Days within Day 1 to Day 28
Time frame: Day 1 to Day 28
Phase I: Change in Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) from Baseline
Time frame: Day 1 to Day 28
Phase I: Change in Arterial Potential of Hydrogen (pH) from Baseline
Time frame: Day 1 to Day 28
Phase I: Change in Arterial Partial Pressure of Oxygen (PaO2) from Baseline
Time frame: Day 1 to Day 28
Phase I: Change in Arterial Partial Pressure of Carbon Dioxide (PaCO2) from Baseline.
Time frame: Day 1 to Day 28
Phase I: Change in Arterial Lactate from Baseline
Time frame: Day 1 to Day 28
Phase I: Change in Sequential Organ Failure Assessment (SOFA)-2 Score from Baseline
Time frame: Day 1 to Day 28
Phase II: Difference in All-cause Mortality Compared to Placebo at Day 7, Day 14, Day 28, Day 90, and Day 180
Time frame: Day 7, Day 14, Day 28, Day 90, and Day 180
Phase II: Difference in ICU-Free Days and Organ Support-Free Days Compared to Placebo within Day 1 to Day 28
Time frame: Day 1 to Day 28
Phase II: Difference in Change of Arterial Partial Pressure of Oxygen/Fraction of Inspired Oxygen Ratio (PaO2/FiO2) Compared to Placebo
Time frame: Day 1 to Day 28
Phase II: Difference in Change of Arterial Potential of Hydrogen (pH) Compared to Placebo.
Time frame: Day 1 to Day 28
Phase II: Difference in Change of Arterial Partial Pressure of Oxygen (PaO2) Compared to Placebo.
Time frame: Day 1 to Day 28
Phase II: Difference in Change of Arterial Partial Pressure of Carbon Dioxide (PaCO2) Compared to Placebo
Time frame: Day 1 to Day 28
Title: Phase II: Difference in Change of Arterial Lactate Compared to Placebo
Time frame: Day 1 to Day 28
Phase II: Difference in Change of Sequential Organ Failure Assessment (SOFA)-2 Score Compared to Placebo
Time frame: Day 1 to Day 28
Phase II: Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. There are no plans to share individual participant data at this time.
Related trials for ARDS (Acute Respiratory Distress Syndrome)
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
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)
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GKL-006RTU injection in people with ARDS (Acute Respiratory Distress Syndrome), run by Beijing Gene Key Life Technology Co., Ltd.
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 6 inclusion and 17 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: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Du, M.D. (+86-10-69151188, dubin98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Incidence and Severity of Adverse Events and Serious Adverse Events (time frame: Day 1 to Day 180). The study lists 2 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 30 Sep 2026.