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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • NCR101 injection

    Biological/Vaccine

    Subjects will receive one NCR101 injection in Single Ascending Dose(SAD)and receive 4 NCR101 injections in Multiple Ascending Dose(SAD).

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: NCR101 injectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
4 weeks after administration of SAD and multiple ascending dose (MAD)

Secondary outcomes

1

Diffusion capacity of the lungs for carbon monoxide(DLCO)

Change from baseline in the result of DLCO

Time frame
4 weeks, 12 weeks, 24 weeks, 48 weeks
2

Forced vital capacity (FVC)

Change from baseline in the result of FVC

Time frame
4 weeks, 12 weeks, 24 weeks, 48 weeks
3

Forced expiratory volume in 1 second (FEV1)

Change from baseline in the result of FEV1

Time frame
4 weeks, 12 weeks, 24 weeks, 48 weeks
4

6-min walk test (6MWT)

Change from baseline in the result of 6MWT

Time frame
4 weeks, 12 weeks, 24 weeks, 48 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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