Chronic obstructive pulmonary disease, asthma Respiratory
Conditions
Interventions
Part A: SAD, healthy adult participants:
Eligible healthy participants for the SAD part will be enrolled and randomized to receive a single administration (SC) of QX031N or placebo at a ratio of 3:1.
Sponsors
Qyuns Therapeutics Co., Ltd
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: All participants: 1. Signed Informed Consent Form (ICF), and ability and willingness to comply with all aspects of the protocol according to the International Council for Harmonisation (ICH) and local regulations, including completion of procedures, interviews, questionnaires, assessments for the duration of the study. 2. Agreement to adhere to the contraception requirements described in Section 5.4.2 of the protocol. 3. Male participants weighing =50 kg, female participants weighing =45 kg, with a body mass index (BMI) between 18 and 32 kg/m2 (inclusive). 4. Healthy participants must be 18 to 65 years of age, inclusive, at the time of signing the Informed Consent Form (ICF). 5. Health status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, serology, coagulation, and urinalysis. COPD participants: 6. Between 40 and 75 years of age inclusive, at the time of signing the informed consent. 7. Confirmed diagnosis of COPD for >6 months, as defined by the GOLD guidelines. 8. Documented history of COPD with a post-bronchodilator FEV1/FVC <0.70 and a post bronchodilator FEV1 =50% predicted at screening. 9. Using maintenance inhaled therapy that may include inhaled corticosteroids and/or long-acting beta-agonist and/or long-acting muscarinic antagonist as separate inhaler(s) or in combination preparation(s). 10. Smoker or an ex-smoker with a smoking history of at least 10 pack years. The following equation should be used to calculate pack years: Pack years = (cigarettes smoked per day/20)* number of years of smoking Asthma participants: 11. Between 18 and 75 years of age inclusive, at the time of signing the informed consent. 12. A physician diagnosis of asthma (mild or moderate, as defined by the Global Initiative for Asthma [GINA], 2025) at least 12 months prior to the start of the study. 13. Demonstrated post-bronchodilator reversibility of FEV1 =12% and =200 ml at Screening or at least one of the following documented historic evidence of lung function variability within 5 years prior to Screening: 13.1. Post-bronchodilator reversibility of FEV1 =12% and =200 ml 13.2. Positive response to methacholine/histamine challenge (provocative concentration causing a decrease in FEV1 by =20% [PC20] of <8 mg/mL) 13.3. Positive response to mannitol challenge (decrease in FEV1 by =15% with =635 mg of cumulative mannitol dosing, or a 10% decrease in FEV1 between two consecutive mannitol doses) 13.4. Positive response to hypertonic saline challenge (decrease in FEV1 by =15% with inhalation of a provocation dose of =23 g 4.5% hypertonic saline) 13.5. Positive response to exercise challenge test (decrease in FEV1 by =10% and =200 ml) 13.6. Variation of FEV1 of =12% and = 200 mL between any two clinical visits, outside of respiratory infections 13.7. Increase in FEV1 by =12% and =200 mL from baseline after 4 weeks of ICS containing treatment, outside of respiratory infections 14. Using the following asthma therapy: 14.1. As needed only short-acting beta-agonist or as needed only inhaled corticosteroid-long acting beta-agonist combination therapy OR 14.2. Regular maintenance inhaled asthma therapy that is stable for at least 3 months prior to screening. Acceptable maintenance inhaler options include: 14.2.1. Low to medium daily dose inhaled corticosteroid (=500 mcg of fluticasone pro
Exclusion criteria
Exclusion criteria: All Participants: 1. Pregnant, breastfeeding, or intending to become pregnant during the study or within the timeframe in which contraception is required (see Section 5.4.2 of the protocol). Participants of childbearing potential (POCBP) must have a negative blood (serum) pregnancy test result at the screening visit. 2. Those who previously received drugs targeting TSLP and IL-33. 3. Those with known diseases prior to screening, with the exception of COPD in Part C and with the exception of asthma in Part D, that are considered clinically significant or affect the study by the Investigator, including but not limited to nervous system, cardiovascular system, respiratory system, hematological system, endocrine system, urinary system, digestive system, skeletal system, metabolic, psychiatric, infectious, ophthalmic, gynecological (female participants) diseases. 4. Current or chronic history of clinically significant liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 5. Those who have a known allergy history to drugs or other substances, or clinically significant, acute and/or uncontrolled allergic disease, and are considered by the Investigator to be at high risk if participating in this study or judged by the Investigator to be possibly allergic to the study drug or any component of the study drug. 6. Infections: 6.1. Those with known or suspected history of immunosuppression, including opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystis, and aspergillosis), should be excluded even if the infection has resolved; 6.2. Those with a history of recurrent severe infections and underlying conditions predisposing to infections (with the exception of COPD in part C and with the exception of asthma in Part D), 6.3. Those with a history of disseminated herpes simplex infection, or recurrent (>1 episode) or disseminated herpes zoster, 6.4. Those who have systemic acute or chronic infection requiring treatment with antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 4 weeks prior to screening, or herpes simplex infection within 2 weeks prior to screening, or any infections (including chronic or localized infections) within the 7 days prior to screening, 6.5. Those with parasitic infestation within 6 months prior to screening. 7. Those with autoimmune disease or using systemic immunosuppressive therapy for autoimmune disease. 8. A personal history of severe hypertension, arrhythmia, or a family history of sudden unexplained death, long QT, familial cardiac syndrome, or cardiomyopathy. 9. Those with a history of malignant neoplasm within 5 years of screening or any evidence of active malignancy, except for completely excised or treated localised carcinoma of the skin or carcinoma in situ. 10. Treatment with immunomodulatory, immunosuppressive therapy (e.g., methotrexate, leflunomide, sulfasalazine, troleandomycin, oral gold, cyclosporine, azathioprine) within 3 months or 5 drug half-lives prior to the screening visit (whichever is longer) or planned during the study. 11. Treatment with a licensed biologic agent for any indication, including COPD or asthma (e.g., omalizumab, dupilumab, tezepelumab, anti-tumor necrosis factor (TNF) therapies, and/or anti-IL-5 therapies) within 3 months or 5 drug-elimination half-lives (whichever is longer) prior to screening or planned during the study. 12. Treatment with m
Countries
New Zealand
Contacts
Public ContactXiao Liu
Outcome results
None listed