A Phase I Clinical Trial of Meplazumab in Healthy Volunteer

NCT04369586 | Completed Phase 1

• 1 other identifier: MPZ-I-01
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0

  Nature, incidence, and severity of AEs/SAEs, and the relationship to meplazumab treatment.

  0-28 days

Secondary Outcomes (4)

• Pharmacokinetic assessments of meplazumab- AUC0-tn

  0-28 days

• Pharmacokinetic assessments of meplazumab- AUC0-∞

  0-28 days

• Pharmacokinetic assessments of meplazumab-half life time

  0-28 days

• Pharmacokinetic assessments of meplazumab-Cmax

  0-28 days

Study Arms (7)

meplazumab dose 1

EXPERIMENTAL

0.06mg/kg for single dose

Drug: meplazumab for injection; Drug: Placebo

meplazumab dose 2

EXPERIMENTAL

0.12mg/kg for single dose

Drug: meplazumab for injection; Drug: Placebo

meplazumab dose 3

EXPERIMENTAL

0.2mg/kg for single dose

Drug: meplazumab for injection; Drug: Placebo

meplazumab dose 4

EXPERIMENTAL

0.3mg/kg for single dose

Drug: meplazumab for injection; Drug: Placebo

meplazumab dose 5

EXPERIMENTAL

0.42mg/kg for single dose

Drug: meplazumab for injection; Drug: Placebo

meplazumab dose 6

EXPERIMENTAL

0.56mg/kg for single dose

Drug: meplazumab for injection; Drug: Placebo

meplazumab multiple dose

EXPERIMENTAL

0.3mg/kg for double doses, 1 dose/week

Drug: meplazumab for injection; Drug: Placebo

Interventions

meplazumab for injection DRUG

single dose: 6 dose level, multiple dose: 0.3mg/kg/dose

meplazumab dose 1; meplazumab dose 2; meplazumab dose 3; meplazumab dose 4; meplazumab dose 5; meplazumab dose 6; meplazumab multiple dose

Placebo DRUG

placebo

meplazumab dose 1; meplazumab dose 2; meplazumab dose 3; meplazumab dose 4; meplazumab dose 5; meplazumab dose 6; meplazumab multiple dose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≤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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Interventions

meplazumab; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2020
• First Posted: April 30, 2020
• Study Start: April 25, 2020
• Primary Completion: August 18, 2020
• Study Completion: November 20, 2020
• Last Updated: April 9, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)