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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05659927
• Other study ID #: MG-ZG122-01
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 9, 2023
• Est. completion date: March 23, 2024

Study information

• Verified date: February 2024
• Source: Shanghai Mabgeek Biotech.Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine the safety and tolerability of MG-ZG122 in Chinese healthy adult subjects

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: March 23, 2024
• Est. primary completion date: January 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• MG-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.
• Placebo
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.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mabgeek Biotech.Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerability and Safety Analysis	Evaluate for dose escalation for study termination criteria or achievement of MTD	up to 127 days
Secondary	Pharmacokinetic Analysis of Cmax	Evaluate the pharmacokinetic parameters Cmax of MG-ZG122	127 days
Secondary	Pharmacokinetic Analysis of Tmax	Evaluate the pharmacokinetic parameters Tmax of MG-ZG122	127 days
Secondary	Pharmacokinetic Analysis of AUC0-t	Evaluate the pharmacokinetic parameters AUC0-t of MG-ZG122	127 days
Secondary	Pharmacokinetic Analysis of t1/2	Evaluate the pharmacokinetic parameters t1/2 of MG-ZG122	127 days
Secondary	Pharmacokinetic Analysis of AUC0-8	Evaluate the pharmacokinetic parameters AUC0-8 of MG-ZG122	127 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Immunogenicity ADA	Antidrug Antibody (ADA) Incidence (if applicable) and Their Impact on PK, Safety, and Efficacy	127 days
Secondary	Neutralizing Antibody (Nab)	Neutralizing Antibody (Nab) IncidenceIncidence (if applicable) and Their Impact on PK, Safety, and Efficacy	127 days