Type 2 inflammatory diseases, including asthma, atopic dermatitis, and chronic sinusitis with nasal polyps
Conditions
Interventions
Test formulation:TQH2722 injection, 300mg (2mL) per vial, 300mg, single dose, subcutaneous injection
Reference preparation:Reference preparation
300mg (2mL)/vial
300mg, single dose
Subcutaneous injection
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Sign the informed consent form before the trial, and fully understand the purpose of the trial, the procedures, and any possible adverse reactions. 2.Aged 18 to 60 years old (including the boundary values), both men and women are eligible. 3.Women >=45.0 kg, men >=50.0 kg, body mass index (BMI) between 19.0 and 26.0 kg/m^2 (including the boundary values), BMI = weight (kg) / height^2(m^2); 4.The subject is able to communicate well with the researcher, is willing, and can understand and follow the trial protocol to complete the study. 5.The subject agrees to have no plans for conception from the date of signing the informed consent form until 6 months after the last administration, and must use effective non-drug contraceptive methods with a partner of childbearing potential.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant, breastfeeding, or have not engaged in protective sexual activity in the two weeks prior to screening; 2.History of or current heart, endocrine, kidney, liver, gastrointestinal, skin, infectious, blood, neurological, or psychiatric disorders/abnormalities, or related chronic or acute diseases, or eye diseases, deemed by the investigator as unsuitable for participation in the trial; 3.During the screening period, abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, or chest X-ray that are clinically significant; 4.Subjects who test positive for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), human immunodeficiency virus antibody (Anti-HIV), or Treponema pallidum antibody (Anti-TP). 5.Within the first 7 days, the occurrence of clinically significant respiratory infections requiring treatment with antibiotics or antiviral drugs; 6.Those who have undergone surgery within the 4 weeks prior to screening or plan to undergo surgery during the study; 7.Within the past 3 months, individuals who have participated in other clinical trials and taken investigational drugs; 8.Received immunoglobulin or blood products within the past 30 days; 9.Those who have lost or donated more than 400 mL of blood in the previous two months; 10.Potential difficulty with blood draws; those with a history of fainting at needles or at the sight of blood; 11.A history of allergic reactions to another therapeutic monoclonal antibody or biological agent, or any known drug or food allergies, especially in individuals allergic to components similar to those of the study drug; 12.Individuals who received or planned to receive live attenuated or live vaccines within 30 days prior to randomization or during the entire study period (including the follow-up period); 13.Smoked more than 5 cigarettes per day or used an equivalent amount of nicotine or nicotine-containing products within the 6 months prior to randomization and throughout the study (including the follow-up period); 14.Individuals with a history of long-term alcoholism or who consumed more than 14 units of alcohol per week during the 3 months prior to screening and throughout the study period (including the follow-up period) (1 unit = 360 mL of beer, 45 mL of 40% alcohol spirits, or 150 mL of wine), or those with a positive blood alcohol test. 15.Individuals with a history of drug abuse or a positive urine drug screen; 16.Received any approved or investigational biologic within the 4 months prior to randomization or within 5 half-lives (whichever is longer); 17.Took any prescription drugs, over-the-counter drugs, or herbal products within the 4 weeks prior to randomization, excluding vitamin products; 18.Use of any systemic cytotoxic or systemic immunosuppressive agents within the 6 months prior to randomization or during the study, or use of any topical cytotoxic or topical immunosuppressive drugs within 30 days prior to randomization or within 5 half-lives (whichever is longer) or during the study. 19.Related to parasitic infection, exclusion applies if any of the following are met: · Routine stool examination during the screening period is positive for parasite eggs; · History of parasitic infection within 6 months prior to the screening period; · During the 6 months before the screening visit, has traveled to or plans to travel to areas endemic for parasitic infections (including but not limi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability indicators; | — |
Countries
China
Contacts
Public ContactWei Hu
The Second Hospital of Anhui Medical University
Outcome results
None listed