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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.
Interstitial lung disease (ILD) is a group of heterogeneous diseases, including idiopathic pulmonary fibrosis(IPF), hypersensitivity pneumonia, sarcoidosis, and connective tissue-associated interstitial lung disease (CTD-ILD), which is characterized by alveolar unit inflammation and/or fibrinization, leading to the destruction of lung structure and loss of function. In the absence of effective treatment, most ILD may develop diffuse pulmonary fibrosis, leading to structural destruction of lung tissue, diffusion dysfunction, and progressive respiratory failure and death. ILD causes a heavy disease and socio-economic burden, and has become a major public health problem. The target of treatment for interstitial lung disease depends on the type of disease and its clinical manifestations. At present, the existing drugs and treatments such as Pirfenidone and Nintedanib can only alleviate the symptoms of IPF or delay the progression of the disease, and the survival improvement is not obvious, and there is no treatment on the market can cure IPF, Patients with connective tissue have a high burden of lung complications, are prone to ILD complications, and the diagnosis and treatment of ILD are difficult for different CTDs. The evidence to guide the optimization of treatment is limited. Therefore, novel drugs with great therapeutic potential are urgently needed for ILD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NCR101 injection | Experimental | Cohort1:Low dose NCR101 injection; Cohort2:High dose NCR101 injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NCR101 injection | Biological | Subjects will receive one NCR101 injection in Single Ascending Dose(SAD)and receive 4 NCR101 injections in Multiple Ascending Dose(SAD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4 weeks after administration of SAD and multiple ascending dose (MAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Diffusion capacity of the lungs for carbon monoxide(DLCO) | Change from baseline in the result of DLCO | 4 weeks, 12 weeks, 24 weeks, 48 weeks |
| Forced vital capacity (FVC) | Change from baseline in the result of FVC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Ren, M.Pharm | Contact | 021-64369181 | yqli@nuwacell.com | |
| Tao Ren, MD | Contact | 021-64369181 |
| Name | Affiliation | Role |
|---|---|---|
| Tao Ren, MD | Shanghai 6th People's Hospital | Principal Investigator |
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| 4 weeks, 12 weeks, 24 weeks, 48 weeks |
| Forced expiratory volume in 1 second (FEV1) | Change from baseline in the result of FEV1 | 4 weeks, 12 weeks, 24 weeks, 48 weeks |
| 6-min walk test (6MWT) | Change from baseline in the result of 6MWT | 4 weeks, 12 weeks, 24 weeks, 48 weeks |
| St George's Respiratory Questionnaire (SGRQ) | Change from baseline in the result of SGRQ | 4 weeks, 12 weeks, 24 weeks, 48 weeks |
| Dyspnea index | Change from baseline in the result of Dyspnea index | 4 weeks, 12 weeks, 24 weeks, 48 weeks |
| high-resolution computed tomography (HRCT) Score | Change from baseline in the result of | 24 weeks, 48 weeks |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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