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Acute Respiratory Distress SyndromePhase 1/2NCT06038916

To Evaluate The Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

A Phase 1/2 study testing STSA-1002 Injection in people with Acute Respiratory Distress Syndrome, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 30 sites in China.

Completed

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

Official record
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Trial summary

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Respiratory Distress Syndrome
What is being tested?
STSA-1002 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
30 sitesChina
Study dates
9 Dec 2023to 27 Apr 2025
Phase
Phase 1/2
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old≤Age≤85 years old;
  • Pathogen results indicate respiratory viral infection;
  • Acute respiratory distress syndrome (ARDS) caused by viral pneumonia;
  • In 14haode days since the onset of respiratory infective symptoms (in 12 days for non-invasive mechanical ventilation patients);
  • PaO₂/FiO₂ ≤200 mmHg based on arterial blood gas analysis prior to randomization;
  • Most recent peripheral blood lymphocyte count ≤0.8×10^9/L prior to randomization;
  • Patients (including patients' partners) has no plans for conception during the study period and within 4 months following the last dose, and agrees to use appropriate and effective contraception (e.g., birth control pills, condoms);
  • Willing to participate in the study and signs the informed consent form

Who cannot join

  • Use of ECMO before the first administration;
  • More than 48 hours of invasive mechanical ventilation prior to the first dose;
  • Based on the researchers' overall assessment, the patient's condition improved within the first 48 hours prior to the initial dosing (predictable improvement in oxygenation indicators observed within the next 48 hours);
  • Expected survival period of less than 24 hours or a history of cardiac arrest within 4 weeks prior to screening;
  • Recent history of stroke or acute coronary syndrome;
  • Diagnosed with fungal pneumonia (Aspergillus, Mucor, Cryptococcus, or Pneumocystis jirovecii pneumonia);
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  • Suspected or known cytomegalovirus infection;
  • Suspected or known active tuberculosis;
  • Experienced prolonged fluid resuscitation-resistant septic shock.
  • Severe chronic respiratory failure;
  • Deemed by the investigator as difficult to wean from ventilation due to severe underlying diseases;
  • Cardiogenic pulmonary edema or congestive heart failure;
  • Liver dysfunction;
  • Severe renal impairment or long-term dialysis;
  • Immunocompromised state;
  • A Absolute neutrophil count is excessively low;
  • Severe anemia or active bleeding;
  • Poor compliance with standard treatment;
  • Pregnant or breastfeeding women;
  • Participated in a clinical trial of a new drug and received treatment within 3 months prior to screening;
  • Any condition that the investigator believes may increase the risk to the patient or interfere with the execution of the clinical trial;
  • Known allergy to any component of the investigational drug or its excipients, or a history of hypersensitivity (e.g., allergic to two or more drugs);
  • Any other disease or condition that, in the investigator's opinion, makes the patient unsuitable for participation in this study;

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

China30 sites

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Beijing Luhe Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 101199

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui, 233099

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • The First Affiliated Hospital of Chengdu Medical College

    Chengdu, Sichuan, 610599

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan, 611130

  • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

    Chongqing, Chongqing Municipality, 400038

  • Hangzhou Red Cross Hospital

    Hangzhou, Zhejiang, 310003

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Huaihe Hospital of Henan University

    Kaifeng, Henan, 450001

  • Kaifeng Central Hospital

    Kaifeng, Henan, 475000

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471099

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Zhongda Hospital affiliated to Southeast University

    Nanjing, Jiangsu, 210009

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, Guangxi, 530016

  • Qingdao Municipal Hospital

    Qingdao, Shandong, 266071

  • Renji Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200001

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The Second Hospital of Hebei Medical University City:Shijiazhuang

    Shijiazhuang, Hebei, 050011

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030032

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325035

  • Wuhan Jinyintan Hospital

    Wuhan, Hubei, 430048

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430062

  • The First Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Xiangtan Central Hospital

    Xiangtan, Hunan, 411100

  • The First Affiliated Hospital of Xinxiang Medical College

    Xingxiang, Henan, 453100

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

  • Zibo Municipal Hospital

    Zibo, Shandong, 255000

Other trials in China

About this study

Official title: Phase Ib/II Randomized, Double-blind, Placebo-controlled Evaluation of the Safety and Initial Efficacy of STSA-1002 Injection in Patients With Acute Respiratory Distress Syndrome

To evaluate the safety and initial efficacy of STSA-1002 injection in patients with acute respiratory distress syndrome.

Being tested
STSA-1002 Injection Placebo, STSA-1002 Injection
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.

  • STSA-1002 Injection PlaceboDrug

    Intravenous infusion

  • STSA-1002 InjectionDrug

    Intravenous infusion

Study groups in NCT06038916
Study groupRoleWhat they receive
Placebo groupPlacebo comparatorPatients in this group will receive basal treatment and placebo.
Receives: Drug: STSA-1002 Injection Placebo
Low dose groupExperimentalPatients in this group will receive basal treatment and placebo+ low-dose STSA-1002.
Receives: Drug: STSA-1002 Injection Placebo; Drug: STSA-1002 Injection
High dose groupExperimentalPatients in this group will receive basal treatment and High-dose STSA-1002.
Receives: Drug: STSA-1002 Injection

What is being measured

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

  1. Clinical remission time

    Measured: Baseline to Day28

Secondary outcomes (10)

  1. 28-day all-cause mortality rate

    Measured: Day28 after first dose

  2. Proportion of subjects achieving clinical remission on Day 14 and Day 28

    Measured: Day14, Day28 after first dose

  3. Changes in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14

    Measured: Day3, Day5, Day7, Day10, Day14 after first dose

  4. Change rates in PaO2/FiO2 values from baseline on Day 3, 5, 7, 10, and 14

    Measured: Day3, Day5, Day7, Day10, Day14 after first dose

  5. Proportion of subjects with a decrease in the level of respiratory support by ≥1 grade on Day 28

    Measured: Day28 after first dose

  6. ICU length of stay and total hospitalization time on Day 28 (V10)

    Measured: Day28 after first dose

  7. Proportion of subjects discharged from the ICU on Day 28

    Measured: Day28 after first dose

  8. Proportion of subjects with PaO2/FiO2 > 300 mmHg on Day 28±2 (V10)

    Measured: Day28 after first dose

  9. Time without ventilator use (invasive or non-invasive) within 28 days

    Measured: Day28 after first dose

  10. Proportion of subjects alive and not receiving mechanical ventilation on Day 28

    Measured: Day28 after first dose

Timeline

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

  1. First posted15 Sep 2023
  2. Study start9 Dec 2023
  3. Primary completion20 Mar 2025
  4. Study completion27 Apr 2025

Resources

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
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06038916
Sponsor's protocol ID
STSA-1002-04
Status last verified
Nov 2024
First submitted
8 Sep 2023
Last updated
11 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang Y, Huang X, Cheng Z, Chu Z, Li H, Zhang Y, Jiang M, Gan X, Li L, Yang X, Zhang Z, Suo L, Li Y, Huang X, Wang X, Yun S, Xiang X, Li Z, Cao B. Anti-C5a Antibody STSA-1002 for Patients With ARDS Due to Viral Pneumonia: A Phase 1b/2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. Chest. 2026 May 15:S0012-3692(26)00638-0. doi: 10.1016/j.chest.2026.04.052. Online ahead of print.

    PubMed 42142803

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing STSA-1002 Injection in people with Acute Respiratory Distress Syndrome, run by Staidson (Beijing) Biopharmaceuticals Co., Ltd at 30 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 8 inclusion and 23 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 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 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. 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?

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?

Clinical remission time (time frame: Baseline to Day28). 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 NCT06038916, which also lists 1 linked publication.

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 11 Jul 2025.

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