Asthma
Conditions
Keywords
Asthma
Brief summary
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
Detailed description
Main purpose: To determine the safety and tolerability of MG-ZG122 humanized monoclonal antibody injection (MG-ZG122 for short) in Chinese healthy adult subjects. Secondary objective: To study the pharmacokinetic (PK) characteristics of MG-ZG122 in healthy Chinese adult volunteers, and to provide a basis for the design of clinical trial protocols for subsequent clinical trials; To evaluate the immunogenicity of MG-ZG122 in Chinese healthy adult volunteers; Preliminary exploration of the efficacy of MG-ZG122 in Chinese healthy adult subjects Impact of Biomarkers in Physiology (PD).
Interventions
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
DRUGPlacebo
Single subcutaneous injection. Subjects with a dose of less than or equal to 2 ml were given one injection, and subjects with a dose of more than 2 ml were given two injections. A group 0.5 ml, B group 1 ml, C group 2 ml, D group 4 ml.
Sponsors
Shanghai Mabgeek Biotech.Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Subcutaneous injections were 52.5 mg, 105 mg, 210 mg and 420 mg, respectively. Four patients were included in the 52.5 mg dose group (2 in the drug group and 2 in the placebo group). There were 10 cases in the other 3 dose groups (8 cases in the drug group and 2 cases in the placebo group). In accordance with the principle of dose increment, from low dose to high dose.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
\- 1. The subjects signed the ICF before the study and fully understood the research content, process and possible adverse reactions; voluntarily participated in the study and were able to complete the study according to the program requirements. 2\. Chinese healthy adult subjects aged 18-65 years (including the boundary value) , both male and female; 3. Male volunteers weighing ≥50 kg; women weighing ≥40 kg; body mass index (BMI) within the range of 19.0-26.0 kg/m2 (including boundary values; BMI=weight kg/height 2 m2);
Exclusion criteria
1. Patients with acute or subacute infection (such as fever, cough, urgency, dysuria, abdominal pain, diarrhea and skin infection wounds, etc.) within 2 weeks before screening, or acute or chronic infection within 4 weeks before screening history, and receiving systemic anti-infective treatment; 2. Those who have a history of tuberculosis infection in the past; 3. The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance; 4. Those who are known to be allergic to monoclonal antibody drugs or excipients of MG-ZG122 injection, or food allergies judged by the investigator to be unsuitable to participate in the researcher; 5. Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study; 6. Those who have used any prescription drugs within 2 weeks before administration, those who have used non-prescription drugs or traditional Chinese medicines within 1 week before administration, or those who are expected to use prescription drugs, non-prescription drugs and traditional Chinese medicines during the study period; 7. Those who have received any research non-biological agents within 5 half-lives (if known) or within 3 months (whichever is longer) before administration, or have participated in other clinical trials or plan to participate in other clinical trials during the study period. clinical trial subjects; 8. Those who have special requirements for diet or cannot accept a unified diet; 9. Women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerability and Safety Analysis | up to 127 days | Evaluate for dose escalation for study termination criteria or achievement of MTD |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic Analysis of Tmax | 127 days | Evaluate the pharmacokinetic parameters Tmax of MG-ZG122 |
| Pharmacokinetic Analysis of AUC0-t | 127 days | Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122 |
| Pharmacokinetic Analysis of t1/2 | 127 days | Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122 |
| Pharmacokinetic Analysis of AUC0-∞ | 127 days | Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122 |
| Pharmacokinetic Analysis of Cmax | 127 days | Evaluate the pharmacokinetic parameters Cmax of MG-ZG122 |
| Pharmacodynamic Biomarker Analysis of immunoglobulin E | 127 days | The effect of MG-ZG122 was evaluated by the changes of immunoglobulin E (Immunoglobulin E, IgE) before and after administration at each follow-up time point |
| Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood | 127 days | The effect of MG-ZG122 was evaluated by the changes of the number of eosinophils in peripheral blood before and after administration at each follow-up time point |
| Immunogenicity ADA | 127 days | Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy |
| Neutralizing Antibody (Nab) | 127 days | Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy |
| Pharmacodynamic Biomarker Analysis of serum interleukin-5 | 127 days | The effect of MG-ZG122 was evaluated by the changes of serum interleukin-5 before and after administration at each follow-up time point |
Countries
China
Outcome results
None listed