Adult atopic dermatitis
Conditions
Interventions
Part A Test group 1:QX029N injection 300 mg, single-dose administration
Part A Test group 2:QX029N injection 450 mg, single-dose administration
Part A Test group 3:QX029N injection 600 mg, single-dose administration
Part A Control group :QX005N injection 450 mg, single-dose administration
Part B Test group:QX029N injection 450 mg, single-dose administration
Part B Control group :QX005N injection 450 mg, single-dose administration
Sponsors
Hangzhou First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. When signing the Informed Consent Form (ICF), healthy adults aged between 18 and 45 years (inclusive of the boundaries) are eligible, regardless of gender. 2. Male participants must have a body weight of >= 50 kg, and female participants must have a body weight of >= 45 kg, with a maximum weight of <= 90 kg; the body mass index (BMI, = weight / height squared, kg/m^2)) must fall within the range of 19.0 <= BMI <= 26.0 kg/m^2. 3. Those who have passed comprehensive examinations, including general physical examinations, laboratory tests (complete blood count, blood biochemistry, urine routine, coagulation profile, thyroid function tests, immunological tests, infectious disease screening, etc.), 12-lead electrocardiogram, abdominal ultrasound with color doppler and chest posteroanterior (PA) and lateral radiographs, etc., with no abnormality or with abnormality but without clinical significance. 4. Female subjects of childbearing potential (Women of Childbearing Potential, WOCBP) and male subjects who have not undergone vasectomy agree to use effective contraception for the duration of the trial and for 6 months after the last dose of the test drug: (1) Complete abstinence, periodic abstinence methods (e.g., calendar method, ovulation method, symptom-temperature method, post-ovulation method) are not permitted; (2) In addition to the correct use of condoms by the male partner, the correct use of one of the following listed contraceptive methods must be adhered to: intra-uterine device (IUD) with an annual failure rate of < 1%, female barrier method: cervical or uterine cap with spermicide, vaginal contraceptive ring); Screening visit for female subjects of childbearing potential and baseline visit prior to the first dose of Blood Human Chorionic Gonadotrophin (HCG) pregnancy test results must be negative; male subjects are not eligible for sperm donation during the trial and for 6 months after discontinuation. Note: A WOCBP subject is defined as a female subject who has not reached postmenopausal status (at least 12 consecutive months of amenorrhea with no clear reason other than menopause) after the onset of menstruation and who is not permanently infertile due to surgery (i.e., bilateral oophorectomy and/or bilateral salpingectomy and/or hysterectomy) or other causes as determined by the investigator (e.g., mullerian duct aplasia). 5. Subjects are able to understand the requirements and process of the study , voluntarily participate in the clinical trial and sign the ICF, and are willing and able to comply with study visits and related procedures.
Exclusion criteria
Exclusion criteria: 1. Persons (females) who have had unprotected vaginal intercourse within 14 days prior to randomization, or females who are pregnant or breastfeeding, or subjects who are planning to become pregnant or breastfeed during the study period. 2. Hypersensitivity to any component or excipient of the investigational drug, or a history of hypersensitivity to biological products, or a prior serious adverse reaction to drugs or food. 3. Previous treatment with any of the following: (1) Any administer of prescription medications or systemic administer of Chinese herbal medicines within the 4 weeks prior to randomization, or over-the-counter medications (except vitamin and mineral supplements ) and topical herbs had been administered within 2 weeks prior to randomization; (2) Participation in any investigational drug clinical trial or receipt of any marketed biological agent within 3 months prior to randomization or at least 5 half-lives (whichever is longer) or participation in a clinical trial of a medical device within 3 months prior to randomization; (3) Prior use of QX005N. 4. Subjects received any any live or live-attenuated vaccine within 3 months prior to randomization or planned to administration of any live or live-attenuated vaccine during the study period. 5. Subjects have donated >=400 mL of whole blood within 3 months prior to screening, or subjects have experienced significant blood loss resulting in a total blood loss equivalent to =400 mL within 3 months prior to screening, or subjects have received any blood products within 8 weeks prior to screening. 6. Alcohol misuse (defined as >2 units of alcohol per day/>14 units of alcohol per week, with 1 unit of alcohol consumption equivalent to 200 mL of beer with 5% alcohol content or 25 mL of spirits with 40% alcohol content or 85 mL of wine with 12% alcohol content) or substance misuse within 6 months prior to screening. 7. Consumption of food or beverages containing alcohol, caffeine (e.g., coffee, strong tea, chocolate, etc.), or xanthine-rich (e.g., sardines, animal liver, etc.) foods or beverages within 48 hours prior to randomization. 8. Presence of disease or abnormal test results that, in the opinion of the Investigator, are clinically significant or interfere with the study, including, but not limited to, diseases or abnormalities occurring in the neurological system, cardiovascular system, renal, hepatic, gastrointestinal (e.g., dysphagia, gastrointestinal ulcers), respiratory system, hematological system, metabolic, ophthalmology (conjunctivitis, keratitis), gynecology (in female subjects), or musculo skeletal systems, or infectious diseases. 9. Abnormalities in any of the following laboratory tests are present at the time of screening: (1) Alanine aminotransferase (ALT) > 1.2 times the upper limit of normal; (2) Aspartate aminotransferase (AST) or total bilirubin (except Gilbert's syndrome) > 1.2 times the upper limit of normal; (3) Serum creatinine > 1.1 times the upper limit of normal; (4) Other abnormal laboratory test results that, in the judgment of the Investigator, may affect the subject's ability to complete the trial or interfere with the results of the safety assessment. 10. 12-lead electrocardiogram (ECG) findings during the screening period reveal that QTcF >450 ms. 11. Active or latent tuberculosis infection may be present at screening, or there may be a prior history of active tuberculosis. 12. Hepatitis B (hepatitis B virus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: The pharmacokinetic characteristics of QX029N injection and QX005N injection;Part B: Equivalence of drug exposure levels between a 450 mg dose of QX029N injection and a 450 mg dose of QX005N injection in healthy subjects; | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Dose-exposure relationship of QX029N injection following single-dose subcutaneous administration;Part A: Safety and tolerability of QX029N injection after single subcutaneous dose administration;Part A: Immunogenicity and pharmacodynamic(PD) characteristics of QX029N injection in healthy subjects, including anti-drug antibodies (ADA) against QX005N, ADA against rHuPH20, and total IgE;Part B: PK Characteristics of QX029N injection and QX005N injection;Part B: Safety of QX029N injection and QX005N injection;Part B: Immunogenicity of QX029N injection and QX005N injection in healthy subjects, including ADA against QX005N and ADA against rHuPH20; | — |
Countries
China
Contacts
Public ContactWang Ying
Hangzhou First People's Hospital
Outcome results
None listed