About this trial
The target of this trial is to evaluate the safety, tolerability and preliminary efficacy of NCR101 in the treatment of subjects with interstitial lung disease. The trial contains Single ascending dose(SAD) and Multiple ascending dose(MAD). Subjects will receive at least 1 dose of NCR101.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>18 years old (including threshold), gender not limited;
Meets the diagnosis of interstitial lung disease;
Screening for interstitial lung disease diagnosed by pulmonary imaging within the first 6 months;
For patients undergoing glucocorticoid therapy at the time of screening: the background treatment remained stable during the study period;
Disqualifiers
Individuals with a history of severe allergies or allergies to the main active ingredients or excipients of the investigational drug;
Individuals who have been hospitalized for three or more times due to acute exacerbation of ILD or other respiratory diseases within the previous year prior to screening;
Individuals with a history of mechanical ventilation (invasive or non-invasive) within the past month prior to screening, or those currently requiring oxygen therapy (oxygen therapy duration>15 hours/day);
Individuals who have contracted infectious pneumonia or require intravenous anti-infective treatment within the previous month; Previous history of tuberculosis
Trial design
Single group
Treatments tested in this trial
NCR101 injection
Biological/VaccineSubjects will receive one NCR101 injection in Single Ascending Dose(SAD)and receive 4 NCR101 injections in Multiple Ascending Dose(SAD).
Treatment groups
Trial outcomes
Primary outcomes
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Secondary outcomes
Diffusion capacity of the lungs for carbon monoxide(DLCO)
Change from baseline in the result of DLCO
Forced vital capacity (FVC)
Change from baseline in the result of FVC
Forced expiratory volume in 1 second (FEV1)
Change from baseline in the result of FEV1
6-min walk test (6MWT)
Change from baseline in the result of 6MWT
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: