Tests an infusion of UMC119-06-05 in people with chronic obstructive pulmonary disease

Trial details

Who runs it

Meribank Biotech Co., Ltd.

Trial code

NCT06491043

Record updated

8 July 2024

Original description

This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.Read full original descriptionShow less

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Umc119-06-05 Intravenous Infusion For The Treatment Of Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease

This phase II study is a randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD. Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo.

Inclusion: Between ≥40 and ≤80 years of age, of either sex and of any race; With diagnosis of COPD based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) standard; Has a post-bronchodilator FEV1/FVC ratio <0.70; Has a post-bronchodilator FEV1 predicted value ≥30% and <80%; With a score ≥2 in the mMRC dyspnea scale; With a score ≥10 in the COPD Assessment Test (CAT); With a body weight ≥40 to ≤90 kg; The disease status of COPD has been stable as determined by the investigator, and the standard treatment for COPD was not adjusted within 3 months prior to screening; Is a current or ex-smoker, with a cigarette smoking history of ≥10 years or >10 pack-years; Women of child-bearing potential should have a negative urine pregnancy test at screening, UNLESS they meet the following criteria:; (1)Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with the serum follicle stimulating hormone (FSH) level >40 mIU/mL, OR; (2)6 weeks post-surgical bilateral oophorectomy with or without hysterectomy 11.Heterosexually active subjects must agree to use a double barrier method of birth control (or must have been surgically sterilized/post-menopausal) and not to donate sperms/eggs during the study; 12.Willing to provide written informed consent to participate in the study.

Exclusion: Has evidence of active malignancy or prior history of active malignancy that has not been in complete remission for at least 5 years prior to screening; Has initiated pulmonary rehabilitation (e.g., exercise training) within 3 months prior to screening which, in the opinion of the Principal Investigator (PI), may affect the study's results; Has had a moderate or severe exacerbation of COPD (defined by GOLD standard) or has required mechanical ventilation (not including continuous positive airway pressure [CPAP]) within 30 days prior to screening; Received systemic steroids or other immunosuppressants, immunomodulators, cytotoxic agents, chemotherapy, radiation therapy, or other cell therapies within 28 days or 5 half-lives, whichever is longer, prior to screening; Underwent major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within 30 days prior to screening; With a known history of alcohol abuse or drug abuse within 5 years prior to screening; Participating in another clinical study of new investigational therapies or have received an investigational therapy within 3 months prior to screening; Diagnosed with asthma or other clinically relevant lung disease other than COPD (e.g., restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, bronchiectasis, or lung cancer); Has documented history of uncontrolled heart failure; Has pulmonary hypertension due to left heart condition; Has atrial fibrillation or significant congenital heart defect/disease; With current active infection including pulmonary infection, systemic infection, or severe local infections; With known stage ≥3 chronic kidney disease; With a known history of drug-related anaphylaxis or other severe allergic reactions to drug; Note: "Severe" is defined as Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grade 3 or greater; With known human immunodeficiency virus infection or immunocompromised; Have the following conditions in laboratory tests at screening:; >2 × upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST); or; Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m2; or; White blood cells (WBC) <3.6 × 103/μL; or; Platelet counts <150 × 103/μL; or; Hemoglobin <10 g/dL; or; Spot urine albumin-creatinine ratio (UACR) ≥30 mg/g; or; Clinically significant hematuria or proteinuria deemed by the study investigator; With known allergy or hypersensitivity to any component of the investigational product (IP) formulation (normal saline and human serum albumin [HSA]); Is hospitalized at screening; With known alpha-1 antitrypsin deficiency; Pregnant (or plan to become pregnant within 3 months after study treatment) or lactating; Has a life expectancy of <6 months.

ClinicalTrials.gov NCT06491043