Clinical trial NCT05659927: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Shanghai Mabgeek Biotech.Co.Ltd
Sponsor class: OTHER_GOV
First posted: 2022-12-21
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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:

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;

Primary outcomes:
measure: Tolerability and Safety Analysis
timeFrame: up to 127 days
Secondary outcomes:
measure: Pharmacokinetic Analysis of Cmax
timeFrame: 127 days
measure: Pharmacokinetic Analysis of Tmax
timeFrame: 127 days
measure: Pharmacokinetic Analysis of AUC0-t
timeFrame: 127 days
measure: Pharmacokinetic Analysis of t1/2
timeFrame: 127 days
measure: Pharmacokinetic Analysis of AUC0-∞
timeFrame: 127 days
measure: Pharmacodynamic Biomarker Analysis of serum interleukin-5
timeFrame: 127 days
measure: Pharmacodynamic Biomarker Analysis of immunoglobulin E
timeFrame: 127 days
measure: Pharmacodynamic Biomarker Analysis of the number of eosinophils in peripheral blood
timeFrame: 127 days
measure: Immunogenicity ADA
timeFrame: 127 days
measure: Neutralizing Antibody (Nab)
timeFrame: 127 days
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University
state: Anhui
Study officials:
affiliation: The Second Hospital of Anhui Medical University
name: Hui Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Anhui Medical University
name: Wei Hu
role: PRINCIPAL_INVESTIGATOR
References: