Idiopathic Pulmonary Fibrosis
Conditions
Interventions
Treatment Group:XQ-001 for inhalation: 6 dose groups in the single-dose phase
2 dose groups in the multiple-dose phase
nebulized inhalation administration
Placebo Group:XQ-001 placebo for inhalation: 5 dose groups in the single-dose phase
Sponsors
Clinical Trial Center, West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be included in the study: 1) Healthy adult male or female subjects aged 18-45 years old (including the boundary value, based on the time of signing the informed consent form) at the time of screening; 2) Body mass index (BMI: weight [kg]/height [m]2) is between 18.0 and 28.0 kg/m2 (inclusive), male subjects weigh =50 kg, and female subjects weigh =45 kg; 3) Normal lung function during the screening period, i.e., FEV1 = 80% predicted and FEV1/FVC > 92% predicted; 4) During the screening period, the subjects' vital signs, physical examinations, laboratory tests, 12-lead electrocardiogram (ECG) and chest X-ray showed no abnormalities or abnormalities without clinical significance; 5) Qualified subjects of fertile potential must agree to use a medically approved contraceptive measure (such as intrauterine contraceptive device, contraceptive pills or condoms) during the trial and within 6 months after the trial. Specific contraceptive measures are shown in Appendix 1; and have no plans to donate sperm/eggs during the trial and within 6 months after the trial; 6) Subjects fully understand the purpose, nature, methods and possible adverse reactions of the trial, voluntarily participate and sign a written informed consent form, and can complete the study in accordance with the requirements of the protocol.
Exclusion criteria
Exclusion criteria: If the subject meets one or more of the following criteria, he/she shall not be included in this study: 1) Known severe allergic, non-allergic drug reaction, or multiple drug allergies, or known hypersensitivity reaction to the investigational product (active drug substance or drug product excipients); 2) The presence of symptoms or related medical history of any major disease, including but not limited to heart, liver, kidney disease or other acute or chronic gastrointestinal diseases, respiratory diseases, bone and joint diseases, as well as blood, endocrine, neurological, mental and other systemic diseases, or any other disease or physiological condition that may interfere with the results of the trial; any surgical condition or condition that may significantly affect the absorption, distribution, metabolism and excretion of the drug, or any surgical condition or condition that may pose a hazard to the subjects participating in the trial; such as history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or difficulty urinating, peptic tract ulcer, history of gastrointestinal bleeding, etc; 3) Those who have been diagnosed with or are currently suffering from bronchial asthma, airway hyperresponsiveness, or have history of suspected asthma attacks; 4) Current chronic liver disease or a known history of liver or biliary abnormalities that the investigator determines may affect the trial results; liver function test results at screening are outside the normal range of the research center and are determined by the investigator to be abnormal and clinically significant (two replicate assessments are allowed at the investigator's discretion); 5) Current arrhythmia diseases (symptomatic or asymptomatic) or a history of arrhythmia determined by the investigator to be abnormal and clinically significant; 6) Clinically significant ECG abnormalities, including but not limited to second or third degree atrioventricular block, QRS complex prolongation of more than 120 msec, or QTc interval prolongation (QTcF>450 msec for male subjects and QTcF>470 msec for female subjects, see Appendix 2 for the formula); 7) Heart rate 100 beats/minute at screening, and determined by the investigator to be abnormal and clinically significant; 8) Severe infection occurred within 30 days before the first administration, including cellulitis, infectious pneumonia, sepsis, etc. For subjects with mild infection (such as mild upper respiratory tract infection), the investigator can determine whether they are suitable for inclusion; 9) Received live vaccination within 30 days before the first dose; 10) Suffered from a major clinically significant disease or underwent major surgery within 3 months before the first dose (except for outpatient minor surgeries), or expected to need major surgery during the trial; 11) Those with a known or suspected history of drug abuse within 2 years before screening, or drug abuse within 3 months before screening, or positive drug abuse screening during the screening period and baseline period; 12) Those who have used clinical trial drugs within 3 months before the first dose, or plan to participate in other interventional clinical trials during this study; 13) Those who have used any prescription drugs (including drugs that induce and inhibit liver drug enzymes), over-the-counter drugs, Chinese herbal medicines, and health products within 14
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;Serious adverse event;Clinical examination;Vital signs;12-lead electrocardiogram;Pulmonary function test;Complete Blood Count;Blood Chemistry;Urinalysis;Coagulation test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum blood concentration (Cmax);Time to peak blood concentration (tmax);The area under the plasma concentration-time curve (AUC) from time 0 to time t, where t is the last time point at which the concentration is above the lower limit of quantification (AUC0-t);The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24);The area under the plasma concentration-time curve from 0 to infinity (AUC0-inf);Terminal phase elimination rate constant (?z);Terminal phase elimination half-life (t1/2);Apparent clearance (CL/F);Apparent volume of distribution in the terminal phase (Vz/F);Mean residence time (MRT);The area under the plasma concentration-time curve from time t to infinity as a percentage of the total AUC (AUC_%Extrap);Steady-state minimum plasma drug concentration (Cmin,ss);Steady-state maximum plasma drug concentration (Cmax,ss);Steady-state average plasma drug concentration (Cavg,ss);Steady-state blood drug concentration peak time (tmax);Area under the plasma concentration-time curve (AUC0-t) during the steady-state dosing interval (t);Apparent clearance (CLss/F);Apparent volume of distribution in the terminal phase (Vss/F);Accumulation ratio calculated from AUC (Rac(AUC));Accumulation ratio calculated from Cmax (Rac(Cmax));Trough concentration (Ctrough);Degree of fluctuation (DF); | — |
Countries
China
Contacts
Public ContactZhu Luo
West China Hospital , Sichuan University
Outcome results
None listed