AsthmaPhase 1NCT05659927
Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects
A Phase 1 study testing MG-ZG122 Humanized Monoclonal Antibody Injection in people with Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
Trial summary
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- MG-ZG122 Humanized Monoclonal Antibody Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2023to 23 Mar 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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;
- Those who have a history of tuberculosis infection in the past;
- The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance;
- 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;
- Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
- 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;
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- 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;
- Those who have special requirements for diet or cannot accept a unified diet;
- Women who are lactating and pregnant, or female volunteers of childbearing age have a positive serum pregnancy test;
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: Safety, Tolerability, and Pharmacokinetics of MG-ZG122 in a Single Subcutaneous Injection in Chinese Healthy Adult Subjects: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial
To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects
Read the 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).
- Conditions
- Asthma
- Being tested
- MG-ZG122 Humanized Monoclonal Antibody Injection, Placebo
- Keywords
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MG-ZG122 Humanized Monoclonal Antibody InjectionDrug
Also called MG-ZG122
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| MG-ZG122 first dose group | Experimental | 4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug) Receives: Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo |
| MG-ZG122 second dose group | Experimental | 10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug) Receives: Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo |
| MG-ZG122 third dose group | Experimental | 10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug) Receives: Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo |
| MG-ZG122 forth dose group | Experimental | 10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug) Receives: Drug: MG-ZG122 Humanized Monoclonal Antibody Injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and Safety Analysis
Evaluate for dose escalation for study termination criteria or achievement of MTD
Measured: up to 127 days
Secondary outcomes (10)
Pharmacokinetic Analysis of Cmax
Evaluate the pharmacokinetic parameters Cmax of MG-ZG122
Measured: 127 days
Pharmacokinetic Analysis of Tmax
Evaluate the pharmacokinetic parameters Tmax of MG-ZG122
Measured: 127 days
Pharmacokinetic Analysis of AUC0-t
Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122
Measured: 127 days
Pharmacokinetic Analysis of t1/2
Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122
Measured: 127 days
Pharmacokinetic Analysis of AUC0-∞
Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122
Measured: 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
Measured: 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
Measured: 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
Measured: 127 days
Immunogenicity ADA
Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Measured: 127 days
Neutralizing Antibody (Nab)
Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Measured: 127 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start9 Feb 2023
- Primary completion26 Jan 2024
- Study completion23 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Shanghai Mabgeek Biotech.Co.LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hui Zhao, Principal investigator, The Second Hospital of Anhui Medical UniversityWei Hu, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659927
- Sponsor's protocol ID
- MG-ZG122-01
- Status last verified
- Feb 2024
- First submitted
- 24 Nov 2022
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We may work with other companies to develop follow-up clinical programs in China or global clinical programs
Publications
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.
PubMed 41144273
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability, and Pharmacokinetics of MG-ZG122 in a Single Subcutaneous Injection in Chinese Healthy Adult Subjects: a Single-center, Randomized, Double-blind, Placebo-controlled, Dose-increasing Phase I Clinical Trial
- ClinicalTrials.gov ID
- NCT05659927
- Acronym / sponsor ID
- MG-ZG122-01
- Conditions
- Asthma
- Keywords
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Shanghai Mabgeek Biotech.Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 23 Mar 2024 (estimated)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| MG-ZG122 first dose group | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection, Drug: Placebo4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug) |
| MG-ZG122 second dose group | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection, Drug: Placebo10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug) |
| MG-ZG122 third dose group | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection, Drug: Placebo10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug) |
| MG-ZG122 forth dose group | Experimental | Drug: MG-ZG122 Humanized Monoclonal Antibody Injection, Drug: Placebo10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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);
Key exclusion criteria (9 listed)
- 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;
- Those who have a history of tuberculosis infection in the past;
- The results of physical examination, vital sign measurement, laboratory examination, electrocardiogram, chest X-ray, etc. are abnormal and have clinical significance;
- 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;
- Those who have been vaccinated within 1 month before screening or plan to be vaccinated during the study;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MG-ZG122 Humanized Monoclonal Antibody InjectionAlso: MG-ZG122Single 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. | Drug | MG-ZG122 first dose group, MG-ZG122 forth dose group, MG-ZG122 second dose group, MG-ZG122 third dose group |
| PlaceboSingle 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. | Drug | MG-ZG122 first dose group, MG-ZG122 forth dose group, MG-ZG122 second dose group, MG-ZG122 third dose group |
Primary outcome
Tolerability and Safety Analysis
Time frame: up to 127 days
Evaluate for dose escalation for study termination criteria or achievement of MTD
10 secondary outcomes
Pharmacokinetic Analysis of Cmax
Time frame: 127 days
Pharmacokinetic Analysis of Tmax
Time frame: 127 days
Pharmacokinetic Analysis of AUC0-t
Time frame: 127 days
Pharmacokinetic Analysis of t1/2
Time frame: 127 days
Pharmacokinetic Analysis of AUC0-∞
Time frame: 127 days
Pharmacodynamic Biomarker Analysis of serum interleukin-5
Time frame: 127 days
Pharmacodynamic Biomarker Analysis of immunoglobulin E
Time frame: 127 days
Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood
Time frame: 127 days
Immunogenicity ADA
Time frame: 127 days
Neutralizing Antibody (Nab)
Time frame: 127 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Derived from this study: PubMed 41144273Zhang 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.
- Individual participant dataSharing planned: No. We may work with other companies to develop follow-up clinical programs in China or global clinical programs
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Zhao principal investigator
The Second Hospital of Anhui Medical University
Wei Hu principal investigator
The Second Hospital of Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MG-ZG122 Humanized Monoclonal Antibody Injection in people with Asthma, run by Shanghai Mabgeek Biotech.Co.Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability and Safety Analysis (time frame: up to 127 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659927, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.