Active, not recruitingNCT05659927Updated Feb 23, 2024

Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects

A Phase 1 interventional study of MG-ZG122 Humanized Monoclonal Antibody Injection and Placebo in Asthma, sponsored by Shanghai Mabgeek Biotech.Co.Ltd. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-23.

Sponsored by Shanghai Mabgeek Biotech.Co.Ltd · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 34
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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 studied

Asthma

Browse trials for

Asthma 3,921

Keywords

Asthma

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 34 is below the median of 83 across 2,752 interventional studies indexed under Asthma.

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Lead sponsor

Shanghai Mabgeek Biotech.Co.Ltd is the lead sponsor of 15 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts 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.

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

Exclusion Criteria:

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;
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;

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 34 participants (actual)

Study arms

Experimental
MG-ZG122 first dose group
4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
Drug: MG-ZG122 Humanized Monoclonal Antibody Injection · Drug: Placebo
Experimental
MG-ZG122 second dose group
10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Drug: MG-ZG122 Humanized Monoclonal Antibody Injection · Drug: Placebo
Experimental
MG-ZG122 third dose group
10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Drug: MG-ZG122 Humanized Monoclonal Antibody Injection · Drug: Placebo
Experimental
MG-ZG122 forth dose group
10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Drug: MG-ZG122 Humanized Monoclonal Antibody Injection · Drug: Placebo

Interventions

DrugMG-ZG122 Humanized Monoclonal Antibody Injection
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.
Also known as: MG-ZG122
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.

What researchers measure

Primary outcomes

Tolerability and Safety Analysis
Evaluate for dose escalation for study termination criteria or achievement of MTD
Time frame: up to 127 days

Secondary outcomes

Pharmacokinetic Analysis of Cmax
Evaluate the pharmacokinetic parameters Cmax of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of Tmax
Evaluate the pharmacokinetic parameters Tmax of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of AUC0-t
Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of t1/2
Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122
Time frame: 127 days
Pharmacokinetic Analysis of AUC0-∞
Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 127 days
Immunogenicity ADA
Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Time frame: 127 days
Neutralizing Antibody (Nab)
Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Time frame: 127 days

Study locations

1 site

The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230601, China

References and documents

Individual participant data

Plan to share: No — We may work with other companies to develop follow-up clinical programs in China or global clinical programs

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05659927
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Responsible party: Sponsor
First posted: Dec 21, 2022
Start date: Feb 9, 2023
Primary completion: Jan 26, 2024
Completion: Mar 23, 2024 (estimated)
Last update: Feb 23, 2024

Study contacts

Hui Zhao

principal investigator · The Second Hospital of Anhui Medical University

Wei Hu

principal investigator · The Second Hospital of Anhui Medical University

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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