NCT07344558 A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Patients With Idiopathic Pulmonary Fibrosis
| NCT ID | NCT07344558 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Mannkind Corporation |
| Condition | Idiopathic Pulmonary Fibrosis (IPF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2026-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2025-12-22 with a primary completion date of 2026-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
MKC-NI-002 is a Phase 1b, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in patients with Idiopathic Pulmonary Fibrosis (IPF). The trial consists of Multiple Ascending Doses (MAD) with the primary objective to evaluate safety, tolerability and pharmacokinetics (PK) of MNKD-201 compared to placebo in patients with IPF.
Eligibility Criteria
Inclusion Criteria: 1. Is ≥40 to ≤85 years of age at the time of signing the informed consent form. 2. Diagnosis of IPF 3. Either treatment-naive or is currently on background pirfenidone or nerandomilast on a stable dose for at least 3 months prior to Screening. 4. Has FVC \>45% of predicted of normal, as determined by the central spirometry reader, during Screening. 5. DLCO corrected for hemoglobin \[Visit 1\] ≥40% of predicted of normal, within 12 months of Screening. If no historical DLCO is available prior to Screening, this is to be done during Screening and read locally. 6. Has a body weight \>40 kg (\>88 lbs.) at Screening. 7. For female participants of childbearing potential, agreement to use acceptable birth control 8. For male participants who can father a child and are having intercourse with females of childbearing potential, agreement to use a protocol-recommended method of contraception 9. Is capable of performing spirometry, as required by the study procedures and ATS guidelines. 10. CT chest within 2 years of Screening, consistent with an IPF diagnosis, per investigator assessment. Exclusion Criteria: 1. Known explanation for interstitial lung disease, including but not limited to radiation, sarcoidosis, hypersensitivity pneumonitis, and bronchiolitis obliterans organizing pneumonia. 2. Diagnosis of any connective tissue disease, including but not limited to scleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis, regardless of whether or not it is presumed to be related to their pulmonary fibrosis diagnosis. 3. Major extrapulmonary physiological restriction (e.g., chest wall abnormality, large pleural effusion), as determined by the investigator. 4. Significant Cardiovascular diseases 5. Recent systemic infection within 4 weeks before the Screening visit or symptomatic viral or bacterial infection at time of Screening. 6. Prior hospitalization for confirmed coronavirus disease 2019 (COVID-19), acute exacerbation of IPF or any lower respiratory tract infection within 3 months of Screening. 7. Has a history of asthma, with the exception of resolved childhood asthma. 8. Has known obstructive lung disease 9. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin \>1.5 times the upper limit of normal (ULN) during Screening. 10. Advanced liver and kidney function. 11. Current or recent (within 30 days of Screening) use of nintedanib. 12. Use of prednisone \>10 mg/day within 1 month prior to Screening, or other significant immunosuppression 13. Active lung cancer (primary or metastatic) or any cancer requiring chemotherapy or radiation therapy within 3 years, except appropriately treated non-melanoma skin cancer, localized non-malignant prostate cancer, or in situ carcinoma of uterine cervix. 14. Has participated in another clinical study of a new chemical entity, new device, or a prescription medicine within the 1 month before Screening 15. Current alcohol, medication, or illicit drug abuse 16. Has lost more than 400 mL blood, e.g., as a blood donor, or donor of blood products, during the 3 months prior to Screening. 17. Has received a live vaccine within the 3 months prior to the first dose of study drug. 18. Smokes (any substance including electronic cigarettes and marijuana) within 3 months prior to Screening or is an ex-cigarette smoker who gave up \<1 year ago. 19. Has oxygen requirement of \> 6 liters/min at rest.
Contact & Investigator
Wassim Fares, MD, MSc, FCCP
STUDY DIRECTOR
Mannkind Corporation
Frequently Asked Questions
Who can join the NCT07344558 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 85 Years, studying Idiopathic Pulmonary Fibrosis (IPF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07344558 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07344558 currently recruiting?
Yes, NCT07344558 is actively recruiting participants. Contact the research team at dmckinley@mannkindcorp.com for enrollment information.
Where is the NCT07344558 trial being conducted?
This trial is being conducted at Fresno, United States, Palm Springs, United States, Doral, United States, Hialeah, United States and 5 additional locations.
Who is sponsoring the NCT07344558 clinical trial?
NCT07344558 is sponsored by Mannkind Corporation. The principal investigator is Wassim Fares, MD, MSc, FCCP at Mannkind Corporation. The trial plans to enroll 24 participants.