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UNKNOWNPHASE1

Safety and Preliminary Clinical Activity of Itolizumab in ARDS

A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Acute Respiratory Distress Syndrome Caused by Infectious Pneumonia

NCT05978544•Biotech Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with acute respiratory distress syndrome (ARDS) caused by Infectious Pneumonia.

Detailed Description

The study will enroll approximately 38 subjects in two parts: Part 1 is an open label 3+3 single dose escalation phase. 9-24 patients with ARDS caused by infectious pneumonia across 3 dose cohorts. Part 2 is a randomized phase and will enroll approximately 14 additional participants, randomized in a 1:1 ratio to one of the 2 doses based on efficacy data obtained from Part 1. All participants in this study will receive Itolizumab intravenously for once, investigator discretion to continue with the same dose every 3 days up to 7 days.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female subject aged 18-75 years old (inclusive)
•2. Clinical diagnosis with infectious pneumonia as determined by the investigator
•3. Subject who havd received anti-infective treatment according to clinical practice.
•4. Diagnosis with ARDS according to the following criteria: (i) Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules; (ii) respiratory failure not fully explained by cardiac failure or fluid overload; (iii) Oxygenation (PaO2/FiO2) ≤300.
•5. ARDS diagnosed within 48 hours before administration, and fullfil the criteria of ARDS before administration
•6. Fullfill at least 2 of the following 4 criteria: ① elevated hs-CRP (\>6 ULN); ② elevated IL-6 (\>3 ULN); ③ high serum ferritin (\>500µg/L at any one time or more than 2-fold increase within 48 hours of onset); ④ high D-dimer (\>3 ULN).
•7. Negative result of serum HCG within 72 hours before enrollment for female with potential fertility
•8. Participant or his/her legal representive (when the participant is not capable of giving consent) is able to understand and comply with the planned procedure as required by the protocol, and sign a written informed consent form (ICF)

Exclusion Criteria

•1. ARDS caused by non-infectious pneumonia (e.g., burns, drowning, poisoning, etc.)
•2. Subject who has cardiogenic pulmonary edema, and it is the main cause of respiratory failure
•3. Subject who is at high risk of death within 24 hours regardless of the treatment measures given as determined by the investigator
•4. Subject who is receiving extracorporeal membrane pulmonary oxygenation (ECMO) therapy at the time of screening.
•5. Subject who had received mechanical ventilation for more than 72 hours prior to administration.
•6. Subject with active tumors (other than carcinoma in situ or basal cell carcinoma) that requiring treatment.
•7. Any of the following chronic organ damage or immunosuppression:
•1. Cardiac: cardiac arrest within 7 days prior to screening; New York Heart Association cardiac function class IV at screening;
•2. Pulmonary: oxygen therapy or ventilator-dependent therapy for more than 1 month cumulatively within 6 months prior to screening; pulmonary embolism within 4 weeks prior to screening; pulmonary hypertension, end-stage lung disease, or interstitial lung disease requiring glucocorticoid therapy at screening;
•3. Renal: serum creatinine \> 1.5 ULN or creatinine clearance \< 30 mL/min at screening (Cockcroft-Gault formula, see study protocol annex 5 for details) or on long-term dialysis treatment;
+13 more criteria

Key Dates

Start Date

December 31, 2023

Primary Completion Date

November 30, 2025

Completion Date

December 31, 2025

Last Updated

August 7, 2023

Enrollment

ESTIMATED participants

Conditions

Acute Respiratory Distress Syndrome

Interventions

Itolizumab

DRUG

Contacts

DANDAN Gao

CONTACT

010-51571020 gaodandan@biotechplc.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Preliminary Clinical Activity of Itolizumab in ARDS

Inclusion Criteria

Exclusion Criteria

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