A Phase I Clinical Trial of Meplazumab in Healthy Volunteer

Sponsor

Xijing Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04369586

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and provide a reference for the dosage of meplazumab in phase II clinical trial.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: meplazumab for injection Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

A Single Center, Double-blinded, ,Placebo-controlled Phase I Clinical Trial in Healthy Volunteer to Evaluate Tolerance and Pharmacokinetics of Meplazumab of Injection

Actual Study Start Date :

Apr 25, 2020

Actual Primary Completion Date :

Aug 18, 2020

Actual Study Completion Date :

Nov 20, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: meplazumab dose 1 0.06mg/kg for single dose	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo
Experimental: meplazumab dose 2 0.12mg/kg for single dose	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo
Experimental: meplazumab dose 3 0.2mg/kg for single dose	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo
Experimental: meplazumab dose 4 0.3mg/kg for single dose	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo
Experimental: meplazumab dose 5 0.42mg/kg for single dose	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo
Experimental: meplazumab dose 6 0.56mg/kg for single dose	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo
Experimental: meplazumab multiple dose 0.3mg/kg for double doses, 1 dose/week	Drug: meplazumab for injection single dose: 6 dose level, multiple dose: 0.3mg/kg/dose Drug: Placebo placebo

Outcome Measures

Primary Outcome Measures

Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0 [0-28 days]
Nature, incidence, and severity of AEs/SAEs, and the relationship to meplazumab treatment.

Secondary Outcome Measures

Pharmacokinetic assessments of meplazumab- AUC0-tn [0-28 days]
AUC0-tn
Pharmacokinetic assessments of meplazumab- AUC0-∞ [0-28 days]
AUC0-∞
Pharmacokinetic assessments of meplazumab-half life time [0-28 days]
Pharmacokinetic assessments of meplazumab-Cmax [0-28 days]
Maximum observed plasma concentration of meplazumab (Cmax)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18≤age≤50 years, males or females;
body weight ≥50 kg, body mass index (BMI) should be within 19.0 and 24.0 (both ends included),
Vital signs, physical examination, laboratory examination (blood routine, urine routine, blood biochemical, coagulation, etc.) and electrocardiogram are within the normal range, or beyond the normal range, but the researchers determined that the abnormality has no clinical significance (NCS).
No bad habits, including tobacco addiction (>5 cigarettes per day) or drink addiction (>15 g of alcohol in a day, and more than two days a week for female, or >25 g in a day, and more than two days a week for male; 15 g of alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL light liquor), no history of drug abuse (defined as the use of illegal drugs);
No birth plan during the study and within 6 months of completing the test and are willing to use non-hormonal contraceptive measures;
Have the ability to communicate normally with medical staff and comply with relevant hospital management regulations;
Understand the study and be willing to participate in the study, and sign an informed consent form. Incompetent subjects, willing and able to comply with all trial requirements.

Exclusion Criteria:

History of allergies to drugs, food, protein or specific allergies (asthma, rubella, eczema dermatitis, etc.);
Vital signs, physical examination, routine laboratory tests (blood routine, urine routine, blood biochemistry, coagulation, etc.), 12-lead ECG and other abnormalities and clinical significance;
Positive for SARS-CoV-2 specific IgM and IgG antibodies test;
Fever within 3 days before medication (body temperature ≥38.0 ℃);
Pregnant or lactating women;
Have received or are participating in other clinical trials within 3 months before the screening;
Be diagnosed or suspected to have immunodeficiency or autoimmune diseases; undergo immunosuppressive therapy such as anticancer chemotherapy or radiotherapy before the trial, or have received systemic corticosteroid treatment within the past 6 months;
With a history of acupuncture syncope reaction;
Positive for HBV surface antigen, anti-HCV antibody, anti-HIV antibody, and syphilis antibody test;
Tobacco addiction (>5 cigarettes per day) or drink addiction (>15 g of alcohol in a day, and more than two days a week for female, or >25 g in a day, and more than two days a week for male; 15 g of alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL light liquor), or can not stop smoking and drinking during the study;
Participated in blood donation or blood loss ≥400mL within 3 months before screening;
Patients not suitable to participate in this study by the judgment of the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Xijing Hospital of the Fourth Military Medical University	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Xijing Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xijing Hospital

ClinicalTrials.gov Identifier:

NCT04369586

Other Study ID Numbers:

MPZ-I-01

First Posted:

Apr 30, 2020

Last Update Posted:

Apr 9, 2021

Last Verified:

Apr 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Meplazumab

Study Results

No Results Posted as of Apr 9, 2021