Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed with Plasmodium Falciparum

NCT06040346 | Active Not Recruiting Phase 2

• 1 other identifier: MPZ-MAL-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This phase 2a open-label study to assess Meplazumab in adult patients diagnosed with Plasmodium falciparum

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• The Number of participants with Drug-related SAE, All-cause SAE, Drug-related AESI, All-cause AESI.

  To evaluate the safety of meplazumab in an adult population with uncomplicated, symptomatic P. falciparum infection

  up to 26 weeks

• The Number of Participants discontinuation/ withdrawals due to AE

  To evaluate the safety of meplazumab in an adult population with uncomplicated, symptomatic P. falciparum infection

  up to 26 weeks

Study Arms (1)

Intervention Groups

EXPERIMENTAL

Up to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants/dose level).

Drug: Meplazumab for Injection

Interventions

Meplazumab for Injection DRUG

Meplazumab, an erythrocytic stage-macromolecular antibody drug, has the potential to control clinical occurrence of falciparum malaria. Meplazumab is a humanized anti-CD147 immunoglobulin G subclass 2 (IgG2) monoclonal antibody with strong affinity to CD147. CD147 is expressed on erythrocyte lineage cells throughout erythroid development, including mature erythrocytes and is the target for Plasmodium merozoites to allow reorientation and subsequent invasion of the erythrocytes.

Intervention Groups

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ability to provide informed consent signed by the study participant or legally authorized representative
• Adults 18 to 55 years at the time of signing the informed consent form (ICF)
• Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP), as defined in Section 10.4.
• Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Section 10.4.
• BMI ≥18 to ≤30 kg/m2
• Mono-infection with P. falciparum documented by:
• Microscopically confirmed parasite infection using by Giemsa-stained thick film (refer to the laboratory manual for details) consisting of 1000 - 100,000 asexual parasites /µL of blood and
• Documented fever (≥38.0°C oral, rectal or tympanic; ≥37.5°C axillary) or documented history of fever in previous 24 hours

You may not qualify if:

• Presence of severe malaria (as defined by World Health Organization Guidelines for Malaria 16 February 2021).
• Severe falciparum malaria is defined as one or more of the following, occurring in the absence of an identified alternative cause and in the presence of P. falciparum asexual parasitemia.
• Impaired consciousness: A Glasgow coma score \<11 in adults
• Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance
• Multiple convulsions: More than 2 episodes within 24 h
• Acidosis: A base deficit of \>8 mEq/L or, if not available, a plasma bicarbonate level of \<15 mmol/L or venous plasma lactate ≥5 mmol/L. Severe acidosis manifests clinically as respiratory distress (rapid, deep, labored breathing).
• Hypoglycemia: Blood or plasma glucose \<2.2 mmol/L (\<40 mg/dL)
• Severe malarial anemia: Hemoglobin concentration ≤7 g/dL or a hematocrit of ≤20% in adults with a parasite count \>10,000/μL
• Renal impairment: Plasma or serum creatinine \>265 μmol/L (3 mg/dL) or blood urea \>20 mmol/L
• Jaundice: Plasma or serum bilirubin \>50 μmol/L (3 mg/dL) with a parasite count \>100,000/ μL
• Pulmonary edema: Radiologically confirmed or oxygen saturation \<92% on room air with a respiratory rate \>30/min, often with chest indrawing and crepitations on auscultation
• Significant bleeding: Including recurrent or prolonged bleeding from the nose, gums or venepuncture sites; hematemesis or melena
• Shock: Compensated shock is defined as capillary refill ≥3 s or temperature gradient on leg (mid to proximal limb), but no hypotension. Decompensated shock is defined as systolic blood pressure \<80 mmHg in adults, with evidence of impaired perfusion (cool peripheries or prolonged capillary refill).
• Hyperparasitemia: P. falciparum parasitemia \>10%
• Antimalarial treatment (alone or in combination) during the following periods before Screening:

Sponsors & Collaborators

• Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd: lead

Study Sites (1)

Kisumu County Referral Hospital

Kisumu, Kenya

Location

MeSH Terms

Conditions

Malaria

Interventions

meplazumab; Injections

Condition Hierarchy (Ancestors)

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 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2023
• First Posted: September 15, 2023
• Study Start: April 26, 2024
• Primary Completion: August 1, 2025
• Study Completion: October 9, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KE (1)