NCT04631666已完成1 期
A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Proportion of Patients With Any AE Within 7 d of Study Drug Infusion
研究概览
简要总结
This is the first-in-human phase 1/2a trial of the intravenous administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.
详细描述
The phase 1 component of this trial consists of a single intravenous infusion open-label dose-escalation phase (Groups 1A-1D and Group 2C). Subsequently, the highest tested and tolerated dose will be administered to an expansion cohort of SARS-CoV-2-infected individuals (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or placebo by intravenous infusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Groups 1A-1D
- •SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
- •Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
- •Groups 2C-2D
- •SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
- •Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or ageusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration or Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
- •Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020).
- •Exclusion Criteria (all groups):
- •Known hypersensitivity to any constituent of the investigational medicinal product.
- •Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.
- •Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.
- •HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.
- •Neutrophil count ≤1,000 cells/µl
- •Hemoglobin ≤10 g/dl
- •Platelet count ≤100,000 cells/µl
- •ALT ≥2.0 x ULN
- •AST ≥2.0 x ULN
- •Total bilirubin ≥1.5 ULN
- •eGFR <60 ml/min/1.73m2
- •Pregnancy or lactation.
- •Any vaccination within 14 days prior to DZIF-10c administration.
- •Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.
- •Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.
- •Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
- •History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable).
- •Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.
- •Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.
- •Legally incapacitated individuals
- •Individuals held in an institution by legal or official order
- •If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception
排除标准
- 未提供
结局指标
主要结局
Proportion of Patients With Any AE Within 7 d of Study Drug Infusion
时间窗: 7 days
次要结局
- DZIF-10c Elimination Half Life(0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose)
- DZIF-10c Peak Serum Concentration(0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose)
- DZIF-10c Area Under the Curve(0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose)
- DZIF-10c Clearance(0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose)
- DZIF-10c Volume of Distribution Vz(0, 1, and 4 hours post dose; 1, 3, 7, 14, 21, 28, 56, 90 days post dose)
- Anti-Drug Antibody Development(0, 14, 28, 56, 90 days post dose)
- Anti-Drug Antibody Peak Titer(0, 14, 28, 56, 90 days post dose)
- MMRM SARS-CoV-2 Viral Load Change From Baseline(0, 1, 3, 7, 14, 28 days post dose)
- Time-weighted SARS-CoV-2 Viral Load Change From Baseline(0, 1, 3, 7, 14, 28 days post dose)
研究者
Florian Klein
Investigator
University of Cologne
研究点 (2)
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