Bronchiectasis
Conditions
Interventions
SAD group:The study is designed with 5 dose groups, each planning to enroll 8 subjects. Within each group, 6 subjects will receive the investigational drug YD0293, and 2 subjects will receive a placeb
MAD group:The study design includes 3 dose groups, each enrolling 8 subjects: 6 receiving the investigational drug YD0293 and 2 receiving a placebo. All subjects will undergo 28 days of continuous tre
FE group:In this phase, 14 subjects are randomly divided into Group A and Group B, with 7 subjects in each group.
Group A:
Day 1 (D1): Dosing under fasting conditions.
Day 8 (D8): Dosing after a high
Sponsors
Second Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Healthy subjects, both male and female, in each group; (2) 18 years old< = age< = 45 years old; (3) The weight of men shall not be less than 50kg, and the weight of women shall not be less than 45kg. Body mass index (BMI) = weight (kg) / height ^2 (m^2), 19.0kg/m2< = body mass index (BMI) < = 26.0 kg/m^2; (4) During the screening period, those who have undergone vital signs, physical examination, blood routine, blood biochemistry, coagulation function, urine routine, virological examination, chest X-ray, B-ultrasound and blood pregnancy (female), and the results show no abnormality or abnormality without clinical significance; (5) The results of the 12-lead ECG during the screening period are consistent with normal cardiac conduction and function, including: Sinus rhythm, 50< = heart rate < = 100 bpm; b. QT interval (QTcF) corrected using Fridericia method <=450 ms; c. QRS<=120 ms; d. PR interval <=210 ms; e. The ECG morphology is normal, and there are no clinically significant changes as judged by the investigator. (6) The subject agrees to have no fertility plan and voluntarily take effective contraceptive measures during the trial period and within 3 months after the last dose; (7) The subjects fully understand the purpose, nature, methods and possible adverse events of the trial, voluntarily participate in the trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: Participants will be excluded from the study if they meet any of the following criteria: (1)Pregnant or breastfeeding females; (2)History of chronic diseases or clinical abnormalities that need to be excluded, including but not limited to disorders of the central nervous system, cardiovascular system, kidneys, liver, gastrointestinal tract, respiratory system, hematologic system, metabolic disorders, and musculoskeletal system, or any other physiological condition that could interfere with study results; (3)Active infectious disease requiring antimicrobial treatment at screening. (4)Undergone surgery within 3 months prior to screening and not fully recovered, as judged by the investigator; (5)Previous or current diagnosis of functional dipeptidyl peptidase-1 (DPP1) deficiency leading to periodontitis or palmoplantar keratoderma, with current signs of gingivitis/periodontitis or a history of palm or sole hyperkeratosis or erythema; (6)Confirmed clinically significant allergic reactions (e.g., to food, any component of the investigational drug or placebo, atopic reactions, asthma attacks), which the investigator believes would interfere with the subject’s participation in the trial; (7)Clinically relevant immunosuppressive diseases (including but not limited to immunodeficiency disorders); (8)Abnormal liver function test results (e.g., AST, ALT, GGT) deemed clinically significant by the investigator; (9)Abnormal creatine kinase MB (CK-MB) levels deemed clinically significant by the investigator; (10)Participation in another drug or medical device clinical trial within 3 months prior to screening; (11)Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus IgG antibody, HIV antibodies and p24 antigen, or anti-treponemal antibody at screening, and considered clinically significant by the investigator; (12)Presence of tattoos or scars on any part of the skin that would affect safety assessments, as judged by the investigator; (13)Received vaccination within 1 month prior to screening or during the screening period; (14)History of blood donation within 3 months prior to screening, or plans to donate blood or blood components during the study period, or total blood loss >= 200 mL due to bleeding (excluding menstrual bleeding); (15)Taken any medication within 2 weeks prior to dosing, including strong inhibitors or inducers of CYP3A4 or CYP2D6, traditional Chinese medicine, weight-loss drugs, or supplements; (16)Consumed excessive amounts of tea, coffee, or caffeine-containing beverages (more than 8 cups per day, 1 cup = 250 mL) within 3 months prior to screening; (17)Regular alcohol consumption (more than 14 units per week; 1 unit = 360 mL beer or 45 mL of 40% spirits or 150 mL wine) within 6 months prior to screening or during the screening period, and unable to abstain from alcohol during the trial; (18)Smoked >= 5 cigarettes per day within 6 months prior to screening, or unable to stop using tobacco products during the trial; (19)Unable to refrain from smoking, consuming alcohol (or alcoholic beverages), tea, or coffee from 48 hours before dosing until the last blood draw; (20)Consumed large quantities of grapefruit, pomelo, star fruit, mango, or dragon fruit drinks or foods within 14 days prior to screening or within 48 hours before the first dose; (21)History of drug abuse within 5 years prior to screening or positive urine drug screen (morphine, THC, methamphetamine, MDMA, ketamine); (22)Engaged in strenuous exercise within 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;QT/QTc interval;Neutrophil Elastase Concentration in Blood; | — |
Countries
China
Contacts
Public ContactPan Jie
Second Affiliated Hospital of Soochow University
Outcome results
None listed