A Trial to Evaluate the Safety, Tolerability and Preliminary Efficacy of NCR101 in the Treatment of Subjects With Interstitial Lung Disease

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuwacell Biotechnologies Co., Ltd.

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

Qualifiers

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

Treatments tested in this trial

  • NCR101 injection

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations