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

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MG-ZG122 Humanized Monoclonal Antibody Injection
Placebo
Sponsored by
Shanghai Mabgeek Biotech.Co.Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: 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;

Sites / Locations

  • The Second Affiliated Hospital of Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

MG-ZG122 first dose group

MG-ZG122 second dose group

MG-ZG122 third dose group

MG-ZG122 forth dose group

Arm Description

4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)

10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)

10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)

10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)

Outcomes

Primary Outcome Measures

Tolerability and Safety Analysis
Evaluate for dose escalation for study termination criteria or achievement of MTD

Secondary Outcome Measures

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

Full Information

First Posted
November 24, 2022
Last Updated
April 17, 2023
Sponsor
Shanghai Mabgeek Biotech.Co.Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05659927
Brief Title
Single Dose Clinical Trial of MG-ZG122 in Chinese Healthy Adult Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
August 23, 2023 (Anticipated)
Study Completion Date
November 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mabgeek Biotech.Co.Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MG-ZG122 first dose group
Arm Type
Experimental
Arm Description
4 cases in the 52.5 mg dose group (2 cases of placebo, 2 cases of experimental drug)
Arm Title
MG-ZG122 second dose group
Arm Type
Experimental
Arm Description
10 cases in the 105 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Arm Title
MG-ZG122 third dose group
Arm Type
Experimental
Arm Description
10 cases in the 210 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Arm Title
MG-ZG122 forth dose group
Arm Type
Experimental
Arm Description
10 cases in the 420 mg dose group (2 cases of placebo, 8 cases of experimental drug)
Intervention Type
Drug
Intervention Name(s)
MG-ZG122 Humanized Monoclonal Antibody Injection
Other Intervention Name(s)
MG-ZG122
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerability and Safety Analysis
Description
Evaluate for dose escalation for study termination criteria or achievement of MTD
Time Frame
up to 127 days
Secondary Outcome Measure Information:
Title
Pharmacokinetic Analysis of Cmax
Description
Evaluate the pharmacokinetic parameters Cmax of MG-ZG122
Time Frame
127 days
Title
Pharmacokinetic Analysis of Tmax
Description
Evaluate the pharmacokinetic parameters Tmax of MG-ZG122
Time Frame
127 days
Title
Pharmacokinetic Analysis of AUC0-t
Description
Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122
Time Frame
127 days
Title
Pharmacokinetic Analysis of t1/2
Description
Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122
Time Frame
127 days
Title
Pharmacokinetic Analysis of AUC0-∞
Description
Evaluate the pharmacokinetic parameters AUC0-∞ of MG-ZG122
Time Frame
127 days
Title
Pharmacodynamic Biomarker Analysis of serum interleukin-5
Description
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
Title
Pharmacodynamic Biomarker Analysis of immunoglobulin E
Description
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
Title
Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood
Description
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
Title
Immunogenicity ADA
Description
Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Time Frame
127 days
Title
Neutralizing Antibody (Nab)
Description
Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy
Time Frame
127 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaofeng Cai
Phone
51371305
Ext
021
Email
xiaofeng.cai@mabgeek.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Zhao
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Hu
Organizational Affiliation
The Second Hospital of Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230601
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We may work with other companies to develop follow-up clinical programs in China or global clinical programs

Learn more about this trial

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

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