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

NCT06825169 | Not Yet Recruiting Phase 1

• 1 other identifier: NCR101-1001
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Interstitial Lung Disease (ILD)

Outcome Measures

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

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

Secondary Outcomes (7)

• Diffusion capacity of the lungs for carbon monoxide(DLCO)

  4 weeks, 12 weeks, 24 weeks, 48 weeks

• Forced vital capacity (FVC)

  4 weeks, 12 weeks, 24 weeks, 48 weeks

• Forced expiratory volume in 1 second (FEV1)

  4 weeks, 12 weeks, 24 weeks, 48 weeks

• 6-min walk test (6MWT)

  4 weeks, 12 weeks, 24 weeks, 48 weeks

• St George's Respiratory Questionnaire (SGRQ)

  4 weeks, 12 weeks, 24 weeks, 48 weeks

Study Arms (1)

NCR101 injection

EXPERIMENTAL

Cohort1:Low dose NCR101 injection; Cohort2:High dose NCR101 injection

Biological: NCR101 injection

Interventions

NCR101 injection BIOLOGICAL

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

NCR101 injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• If the patient is undergoing anti-fibrotic therapy (pirfenidone or nintedanib) at the time of screening, they must have received a stable dose for at least 4 weeks at the time of screening and plan to continue receiving this background therapy steadily after entering this study;
• Patients of childbearing age (male and female) must agree to take effective non pharmacological contraceptive measures during the trial period and within 6 months after the last use of medication:
• Voluntarily sign an informed consent form and be able to cooperate in completing research related procedures and checks.

You may not qualify if:

• 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
• Patients with other serious respiratory diseases, such as asthma, those with airway obstruction (FEV1/FVC\<0.7 before using bronchodilators), and those with other clinically significant abnormalities in the lungs;
• Within the first 3 days of enrollment, use high-dose corticosteroids (equivalent to methylprednisolone\>240 mg/day) or irregularly use systemic corticosteroids;

Sponsors & Collaborators

• Nuwacell Biotechnologies Co., Ltd.: lead

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Tao Ren, MD

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Ren, M.Pharm

CONTACT

021-64369181; yqli@nuwacell.com

Tao Ren, MD

CONTACT

021-64369181

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 13, 2025
• Study Start: March 1, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02