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To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MG-ZG122 first dose group | Experimental | 4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug) |
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| MG-ZG122 second dose group | Experimental | 10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug) |
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| MG-ZG122 third dose group | Experimental | 10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug) |
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| MG-ZG122 forth dose group | Experimental | 10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MG-ZG122 Humanized Monoclonal Antibody Injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability and Safety Analysis | Evaluate for dose escalation for study termination criteria or achievement of MTD | up to 127 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic Analysis of Cmax | Evaluate the pharmacokinetic parameters Cmax of MG-ZG122 | 127 days |
| Pharmacokinetic Analysis of Tmax | Evaluate the pharmacokinetic parameters Tmax of MG-ZG122 |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Hui Zhao | The Second Hospital of Anhui Medical University | Principal Investigator |
| Wei Hu | The Second Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | Anhui | 230601 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41144273 | Derived | Zhang X, Zhu L, Zhang Q, Zheng L, Guo J, Zou Q, Yan R, Qin D, Zhang C, Hu W. Safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of MG-ZG122, a long-acting humanized anti-thymic stromal lymphopoietin mAb, in healthy Chinese: a randomized, double-blind, placebo-controlled, dose-escalation, phase I study. Expert Opin Investig Drugs. 2025 Nov;34(11):943-951. doi: 10.1080/13543784.2025.2581666. Epub 2025 Oct 30. |
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We may work with other companies to develop follow-up clinical programs in China or global clinical programs
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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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.
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| Placebo | Drug | 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. |
|
| 127 days |
| Pharmacokinetic Analysis of AUC0-t | Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122 | 127 days |
| Pharmacokinetic Analysis of t1/2 | Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122 | 127 days |
| Pharmacokinetic Analysis of AUC0-∞ | Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122 | 127 days |
| Pharmacodynamic Biomarker Analysis of serum interleukin-5 | The effect of MG-ZG122 was evaluated by the changes of serum interleukin-5 before and after administration at each follow-up time point | 127 days |
| Pharmacodynamic Biomarker Analysis of immunoglobulin E | 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 | 127 days |
| Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood | 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 | 127 days |
| Immunogenicity ADA | Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy | 127 days |
| Neutralizing Antibody (Nab) | Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy | 127 days |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |