Clinical Study of Meplazumab to Treat With Malaria

NCT04327310 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: PMZ201501
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase 1 study will be conducted to explore the dose regimen in humans and to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and toxicological effects of meplazumab in healthy subjects, thus providing a new macromolecule antibody drug for the prevention and treatment of P. falciparum infection.

Conditions

Malaria (Plasmodium Falciparum)

Outcome Measures

Primary Outcomes (2)

• Presence of Anti-antibodies

  collection of blood samples for immunogenicity assessments，using vadiation Anti-body testing assay to test the presence of anti-antibodies

  Time Frame: 71±3 days (throughout the study period)

• Adverse events / serious adverse events

  Recording of adverse events / serious adverse events throughout the study period

  43±3 days (from first dose to end of study)

Secondary Outcomes (9)

• The area under the plasma drug concentration-time curve (AUC)

  43±3 days (from first dose to end of study)

• Maximum Plasma Concentration

  43±3 days (from first dose to end of study)

• Time to Maximum Plasma Concentration

  43±3 days (from first dose to end of study)

• Area under the serum concentration-time curve from time zero extrapolated to infinity

  43±3 days (from first dose to end of study)

• Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration

  43±3 days (from first dose to end of study)

Study Arms (2)

Meplazumab

EXPERIMENTAL

The vial of meplazumab will be reconstituted with 1 mL of water for injection. The required amount of drug solution will be withdrawn and added to 100 mL sterile normal saline (0.9%) for IV infusion. A single dose of meplazumab will be infused over 60 minutes at a constant rate using an infusion pump.

Drug: Meplazumab for Injection

Placebo

PLACEBO COMPARATOR

100ml placebo will be infused over 60 minutes at a constant rate using an infusion pump, single time.

Drug: Sterile normal saline (0.9%)

Interventions

Meplazumab for Injection DRUG

humanized mAb against CD147

Also known as: Meplazumab

Meplazumab

Sterile normal saline (0.9%) DRUG

Sterile normal saline (0.9%)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of giving signed informed consent as described in Appendix 2, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, prior to any study-specific procedures.
• Men and women aged 18 to 55 years (inclusive), with suitable veins for cannulation or repeated venipuncture.
• Total body weight ≥50 kg, and a body mass index between 18 to 32 kg/m2, inclusive.
• Female subjects are eligible to participate if they have a negative pregnancy test at the Screening Visit and on admission to the study center, not lactating
• Male subjects with female partners of childbearing potential must agree to use contraception as detailed in Appendix 7 of this protocol from the time of informed consent until at least 3 months after dosing with the investigational product. Male subjects with female partners that are surgically sterile, or male subjects who have undergone sterilization and have had testing to confirm the success of the sterilization, may also be included.
• Male subjects must not donate sperm from the day of dosing until at least 3 months after dosing with the investigational product.
• Medically healthy with clinically insignificant screening results based on a comprehensive medical history and physical examination as judged by the Principal Investigator.
• Has to agree to abstain from alcohol intake 48 hours before administration of the study treatment and inoculation with P. falciparum, and during the confinement period of the study.
• Able to be compliant with the protocol and attend all scheduled visits.

You may not qualify if:

• Previously treated with study treatment in the present study.
• History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
• Any known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections.
• Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of investigational product.
• History of splenectomy.
• Subjects with history of schizophrenia, bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis.
• Subjects who have been hospitalized within 5 years prior to enrollment for either a psychiatric illness or due to danger to self or others.
• History of an episode of minor depression that required at least 6 months of pharmacological therapy and/or psychotherapy within the last 5 years; or any episode of major depression.
• Presence of clinically significant infectious disease or fever (eg, sublingual temperature ≥38.5°C) within 5 days prior to study treatment administration (Parts A and C) or inoculation with the malaria challenge agent (Part B).
• Hematology, biochemistry, or urinalysis results at Screening or at Day -1 (Parts A and C) or between Day -11 to -9 (Part B) that are outside of Sponsor-approved clinically acceptable laboratory ranges (Appendix 4), or are considered clinically significant by the Investigator. One repeat is permitted at Screening.
• Any positive result at Screening for hepatitis B surface antigen, anti-hepatitis B core antibodies, rapid plasma reagin, anti-hepatitis C virus antibody, and anti-human immunodeficiency virus 1 and 2 antibodies.
• Symptomatic postural hypotension at Screening (confirmed on 2 consecutive readings), irrespective of the decrease in blood pressure, or asymptomatic postural hypotension defined as a decrease in systolic blood pressure ≥20 mmHg within 2 to 3 minutes when changing from supine to standing position.
• Abnormal vital signs at Screening (supine and standing) and on Day 1 (Parts A and C) or pre-inoculation on Day 8 (Part B) (supine), defined as any of the following:
• Systolic blood pressure \<90 or \>140 mmHg.
• Diastolic blood pressure \<40 or \>90 mmHg.

Sponsors & Collaborators

• Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd: lead

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

meplazumab; Injections

Condition Hierarchy (Ancestors)

Malaria; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 31, 2020
• Study Start: March 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-01