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A Phase I Clinical Trial of Meplazumab in Healthy Volunteer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04369586
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 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
Estimated Study Start Date : April 25, 2020
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 30, 2020

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




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


Secondary Outcome Measures :
  1. Pharmacokinetic assessments of meplazumab- AUC0-tn [ Time Frame: 0-28 days ]
    AUC0-tn

  2. Pharmacokinetic assessments of meplazumab- AUC0-∞ [ Time Frame: 0-28 days ]
    AUC0-∞

  3. Pharmacokinetic assessments of meplazumab-half life time [ Time Frame: 0-28 days ]
  4. Pharmacokinetic assessments of meplazumab-Cmax [ Time Frame: 0-28 days ]
    Maximum observed plasma concentration of meplazumab (Cmax)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04369586


Locations
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China, Shaanxi
Xijing Hospital of the Fourth Military Medical University Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Ping Zhe, Dr    +86-029-84771581    zhuping@fmmu.edu.cn   
Contact: Ai-Dong Wen, Dr    +86-029-84773636    adwen@fmmu.edu.cn   
Sponsors and Collaborators
Xijing Hospital
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT04369586    
Other Study ID Numbers: MPZ-I-01
First Posted: April 30, 2020    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No