PACTR202310786332004尚未招募2 期
A Phase 2a, Multicenter, Open-label, Dose-finding, Dose Escalation Study of Meplazumab in Adult Patients Diagnosed with Uncomplicated Plasmodium falciparum Malaria
Jiangsu Pacific Meinuoke Biopharmaceutical Co. Ltd. PMBP0 个研究点目标入组 60 人开始时间: 2023年9月22日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •. Ability to provide informed consent signed by the study participant or legally authorized
- •representative
- •2. Adults 18 to 55 years at the time of signing the informed consent form (ICF)
- •3. Female participants are eligible to participate if they do not qualify as a woman of
- •childbearing potential (WOCBP), as defined in Section 10.4.
- •4. Male participants who engage in heterosexual intercourse must agree to use protocol
- •specified method(s) of contraception as described in Section 10.4.
- •5. BMI =18 to =30 kg/m2
- •6. Mono-infection with P. falciparum documented by:
- •Microscopically confirmed parasite infection using Giemsa-stained thick film (refer to the
- •laboratory manual for details) consisting of 1000 – 100,000 asexual parasites /µL of blood
- •Documented fever (=38.0°C oral, rectal or tympanic; =37.5°C axillary) or documented
- •history of fever in previous 24 hours
排除标准
- •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.
- •o Impaired consciousness: A Glasgow coma score <11 in adults
- •CONFIDENTIAL Protocol MPZ-MAL-01 [Amendment 1]
- •o Prostration: Generalized weakness so that the person is unable to sit, stand or walk
- •without assistance
- •o Multiple convulsions: More than 2 episodes within 24 h
- •o 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).
- •o Hypoglycemia: Blood or plasma glucose <2.2 mmol/L (<40 mg/dL)
- •o Severe malarial anemia: Hemoglobin concentration =7 g/dL or a hematocrit of =20%
- •in adults with a parasite count >10,000/µL
- •o Renal impairment: Plasma or serum creatinine >265 µmol/L (3 mg/dL) or blood
- •urea >20 mmol/L
- •o Jaundice: Plasma or serum bilirubin >50 µmol/L (3 mg/dL) with a parasite
- •count >100,000/ µL
- •o 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
- •o Significant bleeding: Including recurrent or prolonged bleeding from the nose,
- •gums or venepuncture sites; hematemesis or melena
- •o 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).
- •o Hyperparasitemia: P. falciparum parasitemia >10%
- •2. Antimalarial treatment (alone or in combination) during the following periods before
- •Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks
- •prior to Screening.
- •Amodiaquine, chloroquine within 4 weeks prior to Screening.
- •Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine,
- •lumefantrine or any other antimalarial treatment or antibiotic with antimalarial activity
- •(including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and
- •azithromycin) within 14 days prior to Screening.
- •Any herbal products or traditional medicines, within the past 7 days.
- •3. Previous participation in any malaria vaccine study or received malaria vaccine within 3
- •months of Screening Visit.
- •4. Known allergy to any study medication, including allergy to any component of protocol
- •prescribed rescue treatment i.e., country-specific ACT regimen.
- •CONFIDENTIAL Protocol MPZ-MAL-01 [Amendment 1]
- •5. Any clinically important illness as judged by the investigator, including but not limited to
- •a history of clinically significant chronic respiratory disease (eg, chronic obstructive
- •pulmonary disease [COPD] or asthma), medical/surgical procedure, or trauma within 4
- •weeks of the first administration of investigational product.
- •6. Participants participate in another clinical study. There will be a need for washout with 5
- •half-lives depending on the study treatment or 30 days, whichever is longer.
- 另有 2 项未显示
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