Acute Respiratory Distress Syndrome (ARDS)Phase 2NCT07319351

Safety and Preliminary Efficacy of TISA-818 Injection in Patients With Acute Respiratory Distress Syndrome

A Phase 2 study testing TISA-818-Inj in people with Acute Respiratory Distress Syndrome (ARDS), run by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled Phase II clinical study of TISA-818-Inj in patients with ARDS to evaluate the safety, preliminary efficacy, and population PK (Pop PK) profile of TISA-818-Inj in adult ARDS patients. Totally 60 subjects with ARDS are planned to be included in this study. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Acute Respiratory Distress Syndrome (ARDS)
What is being tested?: TISA-818-Inj
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteChina
Study dates: 12 Oct 2023to 15 Sep 2025
Phase: Phase 2
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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily participate in the clinical study, and patients themselves or their guardians fully understand and are informed of the study and sign the informed consent form, agree to follow and be able to complete all study procedures;
Male or female subject age 18-80 years of signing the informed consente;
Meets all the following diagnostic criteria:
Timing: Within 1 week of a known clinical insult or new or worsening respiratory symptoms;
Chest imaging: Chest radiography or CT scan showing bilateral opacities - not fully explained by effusions, lobar/lung collapse, or nodules;
Origin of edema: Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment to exclude hydrostatic edema if no risk factor present;

Show all 11Show fewer

Oxygenation: PaO2/FiO2 ≤ 300 mmHg with PEEP ≥ 5 cm H2O or PaO2/FiO2 ≤ 300 mmHg with high flow nasal oxygen ≥30 L/min;
ARDS caused by pneumonia infection;
C-reactive protein (CRP) level is higher than the upper limit of normal (ULN) value;
Be able to receive the investigational drug within 72 hours after the first diagnosis of the ARDS;
Men and women of childbearing potential (women of childbearing potential include premenopausal women and those within 2 years of menopause) who are willing to use highly effective contraception (condom, contraceptive sponge, gel, film, intrauterine device, oral or injected contraceptives, subcutaneous implants, etc.) from signing the informed consent form through 6 months after the last dose of the investigational drug.

Who cannot join

ARDS caused by drowning or COVID-19;
Be allergic to the test drug or excipients;
Have an expected survival of ≤ 72 hours as judged by the investigator;
Have other current or previous serious pulmonary disease at screening, including but not limited to WHO Class III or IV pulmonary hypertension, chronic lung disease requiring long-term oxygen therapy, or previous lung transplantation;
Have a current or previous active cardiovascular disease at screening, including but not limited to Chronic heart disease (New York Heart Association functional class IV), episodes of cardiac arrest or acute myocardial infarction within 4 weeks before screening;
Severe hemodynamic instability at screening (defined as norepinephrine dose > 0.5 μg/kg/min or dopamine dose > 20 μg/kg/min);

Show all 19Show fewer

Chronic hemodialysis and known severe renal impairment (creatinine clearance rate<30 mL/min, appendix 8);
The following laboratory abnormal values exist:
Bone marrow function: platelet count <30 × 109/L, hemoglobin<7.0 g/dL;
Liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 times the ULN value and serum bilirubin (T-Bil) >2 times the ULN,;
Receiving extracorporeal membrane oxygenation (ECMO), continuous renal replacement therapy (CRRT), plasma exchange, hemoperfusion/adsorption, or any other forms of extracorporeal life support at randomization;
Have scheduled or anticipated surgery within 28 days after the first administration;
Pregnant or lactating women;
Those who have used ulinastatin, thymalfasin, Xuebijing, sivelestat sodium and montelukast sodium within 24 hours before starting treatment or systemic treatment with immunosuppressants or other anti-inflammatory agents within 14 days prior to the first administration;
The dosage of methylprednisolone used before treatment is > 40 mg/day (or equivalent glucocorticoid) for more than 7 days or the dosage of methylprednisolone used is > 280 mg within 7 days before starting treatment;
Those who use any other investigational medicinal product within 28 days before starting treatment;
The presence of active pulmonary tuberculosis determined by the investigator, or other active infections that investigator believes may affect the participation or affect the outcome;
Patients with malignant tumors requiring treatment in the past 2 years or during screening (skin basal-cell carcinoma, breast/cervical carcinoma in situ, papillary thyroid carcinoma, and other malignant tumors that have been treated and have been effectively controlled in the past 2 years or at the time of screening, can be included in this study if they are judged suitable by investigator);
Judgement by the investigator that participation in this study is not in line with the patient's best interests or other conditions that make participation in this study inappropriate, such as poor compliance.

Trial locations and contacts

1 site in 1 country.

China1 site

China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate Safety and Preliminary Efficacy of TISA-818-Inj in Patients With Acute Respiratory Distress Syndrome

Totally 60 subjects with ARDS are planned to be included in this study. Subjects will be assigned to the 6 mg twice daily (BID) TISA-818-Inj group, 12 mg once daily (QD) TISA-818-Inj group, or the placebo control group in a 1:1:1 ratio using a stratified block randomization method.

This study includes a screening period (Day -3 to Day -1), a treatment period (Day 1 to Day 14),a short-term follow-up period (Day 15 to Day 60) and a long-term follow-up period (Day 61 to Day 180). Consenting subjects will be screened for eligibility, according to study-specific inclusion/exclusion criteria.

Conditions: Acute Respiratory Distress Syndrome (ARDS)
Being tested: TISA-818-Inj, Placebo
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.

TISA-818-InjDrug
6 mg b.i.d TISA-818-Inj
TISA-818-InjDrug
12 mg q.d. TISA-818-Inj
PlaceboDrug
placebo

Study groups in NCT07319351
Study group	Role	What they receive
6 mg b.i.d TISA-818-Inj	Experimental	Not described Receives: Drug: TISA-818-Inj
12 mg q.d. TISA-818-Inj	Experimental	Not described Receives: Drug: TISA-818-Inj
placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v5.0
Number of participants with TEAEs following administration of TISA-818 injection
Measured: Up to 60 days

Secondary outcomes (5)

Ventilator-free days (VFD)
The number of days within 28 days that do not require invasive mechanical ventilation, non-invasive mechanical ventilation, or high-flow oxygen therapy.
Measured: Up to 28 days
Days without non-invasive mechanical ventilation/ high-flow oxygen therapy
Number of days for patients need non-invasive mechanical ventilation/ high-flow oxygen therapy.
Measured: Up to 28 days
Days without invasive mechanical ventilation
Number of days without invasive mechanical ventilation.
Measured: Up to 28 days
oxygenation index (PFR)
Changes in PFR compared to baseline and PFR improvement rate.
Measured: Day 3, 7, 10, 14, 21, 28
Plasma population pharmacokinetic (Pop PK) characteristics of TISA-818-Inj in patients with ARDS
For PK analysis, blood samples will be collected before and up to 12h after administration at day 1 and day 5. Blood samples will be collected 30min before administration at day 3, 4, 6, 7, 10 and 14. Blood samples will be collected at day21 and day 28.
Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Oct 202315 Sep 2025

First posted6 Jan 2026
Study start12 Oct 2023
Primary completion25 Mar 2025
Study completion15 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Respiratory Distress Syndrome (ARDS)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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07319351
Sponsor's protocol ID: TISA-818-23201
Status last verified: Dec 2025
First submitted: 7 Dec 2025
Last updated: 6 Jan 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The results of this trial will not be published in the International Committee of Medical Journal.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All Acute Respiratory Distress Syndrome (ARDS) trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate Safety and Preliminary Efficacy of TISA-818-Inj in Patients With Acute Respiratory Distress Syndrome
ClinicalTrials.gov ID: NCT07319351
Acronym / sponsor ID: TISA-818-23201
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: EnliTISA (Shanghai) Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 12 Oct 2023 (actual)
Primary completion: 25 Mar 2025 (actual)
Study completion: 15 Sep 2025 (actual)
First posted: 6 Jan 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.

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
6 mg b.i.d TISA-818-Inj	Experimental	Drug: TISA-818-Inj
12 mg q.d. TISA-818-Inj	Experimental	Drug: TISA-818-Inj
placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Voluntarily participate in the clinical study, and patients themselves or their guardians fully understand and are informed of the study and sign the informed consent form, agree to follow and be able to complete all study procedures;
Male or female subject age 18-80 years of signing the informed consente;
Meets all the following diagnostic criteria:
ARDS caused by pneumonia infection;
C-reactive protein (CRP) level is higher than the upper limit of normal (ULN) value;

Key exclusion criteria (19 listed)

ARDS caused by drowning or COVID-19;
Be allergic to the test drug or excipients;
Have an expected survival of ≤ 72 hours as judged by the investigator;
Have other current or previous serious pulmonary disease at screening, including but not limited to WHO Class III or IV pulmonary hypertension, chronic lung disease requiring long-term oxygen therapy, or previous lung transplantation;
Have a current or previous active cardiovascular disease at screening, including but not limited to Chronic heart disease (New York Heart Association functional class IV), episodes of cardiac arrest or acute myocardial infarction within 4 weeks before screening;

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
TISA-818-Inj6 mg b.i.d TISA-818-Inj	Drug	6 mg b.i.d TISA-818-Inj
TISA-818-Inj12 mg q.d. TISA-818-Inj	Drug	12 mg q.d. TISA-818-Inj
Placeboplacebo	Drug	placebo

Primary outcome

Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v5.0
Time frame: Up to 60 days
Number of participants with TEAEs following administration of TISA-818 injection

5 secondary outcomes

Ventilator-free days (VFD)
Time frame: Up to 28 days
Days without non-invasive mechanical ventilation/ high-flow oxygen therapy
Time frame: Up to 28 days
Days without invasive mechanical ventilation
Time frame: Up to 28 days
oxygenation index (PFR)
Time frame: Day 3, 7, 10, 14, 21, 28
Plasma population pharmacokinetic (Pop PK) characteristics of TISA-818-Inj in patients with ARDS
Time frame: Up to 28 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
Individual participant dataSharing planned: No. The results of this trial will not be published in the International Committee of Medical Journal.

Related trials for Acute Respiratory Distress Syndrome (ARDS)

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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TISA-818-Inj in people with Acute Respiratory Distress Syndrome (ARDS), run by EnliTISA (Shanghai) Pharmaceutical Co., Ltd. at 1 site 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 11 inclusion and 19 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: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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 phase mean?

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment Emergent Adverse Events as coded by MedDRA and assessed by CTCAE v5.0 (time frame: Up to 60 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07319351.

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 6 Jan 2026.