asthma, chronic obstructive pulmonary disease
Conditions
Interventions
Group A:MG-ZG122 (dosage 1) vs placebo
Group B:MG-ZG122 (dosage 2) vs placebo
Group C:MG-ZG122 (dosage 3) vs placebo
Group D:MG-ZG122 (dosage 4) vs placebo
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects signed the informed consent form before the trial and fully understood the study content, process and possible adverse effects, voluntarily participated and were able to complete the trial in accordance with the protocol requirements; 2. Healthy Chinese adult male and female volunteers aged 18-65 years (including 18 and 65 years) at the time of signing the informed consent form; 3. Weight >= 50 kg for male; weight >= 40 kg for female; with a body mass index (BMI) in the range of 19.0-26.0 kg/m2 (including borderline values; BMI = weight kg/height2 m2); 4. Subjects (including male subjects) had no reproductive plans and voluntarily used effective non-pharmacological contraception and had no plans to donate sperm or eggs from two weeks prior to screening to 6 months after the end of the trial.
Exclusion criteria
Exclusion criteria: 1. Those who have had or are having diseases with abnormal clinical manifestations that need to be excluded prior to screening, including but not limited to neurological/psychiatric, respiratory, cardiovascular, gastrointestinal (any history of gastrointestinal disease affecting drug absorption), hematological and lymphatic, urinary, endocrine, and immune system diseases; 2. Those with a history of malignant tumors; 3. Those who have been diagnosed with helminth parasitic infection within 6 months prior to screening and have not been treated or have not recovered from standard treatment; 4. Those with acute or subacute infections (e.g., fever, cough, urinary urgency, dysuria, abdominal pain, diarrhea and infected skin wounds) within 2 weeks prior to screening, or those with a history of acute or chronic infection within 4 weeks prior to screening and receiving systemic anti-infective therapy; 5. Those with a previous history of tuberculosis infection; 6. Those with abnormal and clinically significant results of physical examination, vital sign measurement, laboratory tests, electrocardiogram, chest X-ray, etc.; 7. Those who have undergone surgery within 4 weeks prior to administration, or have a history of surgery deemed clinically significant by the investigator, or who are scheduled to have surgery during the trial; 8. Those with known allergy to monoclonal antibody drugs or to MG-ZG122 injection excipients, or food allergy judged by the investigator to be unsuitable for study participation; 9. Those who have received vaccinations within 1 month prior to screening or are scheduled to receive vaccines during the trial; 10. Those who have used any prescription drug within 2 weeks prior to administration, or those who have used over-the-counter drugs or herbal medicines within 1 week prior to administration, or those who are expected to use prescription drugs, over-the-counter drugs and herbal medicines during the trial; 11. Those who have received any marketed or investigational biologic within 5 half-lives (if known) or within 3 months (whichever is longer) prior to administration; 12. Those who have received any investigational non-biological agent within 5 half-lives (if known) or within 3 months (whichever is longer) prior to administration or who have participated in other clinical trials or plan to participate in other clinical trials during the trial; 13. Those with a history of drug use or substance abuse; 14. Those who have donated blood or blood products or lost a significant amount of blood >= 400 mL within 1 month prior to screening or plan to donate blood during the trial; 15. Those with a history of acupuncture or blood sickness or those with postural hypotension; 16. Those who smoked more than 5 cigarettes per day within 3 months prior to screening, or who could not stop using any tobacco-based products during the trial; 17. Those who consumed more than 14 units of alcohol per week (1 unit = 17.7 mL of ethanol, namely 1 unit = 357 mL of beer with an alcohol content of 5% or 43 mL of white wine with an alcohol content of 40% or 147 mL of wine with an alcohol content of 12%) in the 3 months prior to screening, or those who could not stop drinking any alcohol-containing products during the trial; 18. Those who have special requirements for diet or cannot accept a uniform diet; 19. Lactating and pregnant women, or female volunteers of childbearing age with a positive serum pregnancy test; 20. Volunteers who
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma drug concentration;Immunogenicity (ADA/NAb);interlukin-5 in serum;Immunoglobulin E in serum;Number of eosinophils in peripheral blood;Vital signs;Physical examination;Laboratory test;Electrocardiogram;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters;Immunogenicity;Pharmacodynamic biomarker analysis; | — |
Countries
China
Contacts
Public ContactZhao Hui and Hu Wei
The Second Hospital of Anhui Medical University
Outcome results
None listed