A Phase I, first in human, randomized, investigator and participant-blind, placebo-controlled, single- and multiple dose escalation, parallel group study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of QX031N in healthy participants, participants with chronic obstructive pulmonary disease (COPD) and asthma participants
Chronic obstructive pulmonary disease, asthma
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. Part A provisionally plans for 5 sequential escalating single SC dose cohorts and one single IV dose cohort. Part B: MAD, healthy adult participants: Eligible participants for the Part B MAD study will be enrolled and randomized at a ratio of 3:1 to receive multiple doses of QX031N or placebo. Part C and D: COPD and asthma participants (optional): Eligible participants for Parts C and D will be enrolled and randomized at a ratio of 2:1 to receive multiple subcutaneous administrations of QX031N or placebo. Please note that the dose range, frequency and randomisation process are considered Confidential Commercial Information and cannot be disclosed.
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. Demonstrat
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 syst