A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

University of Cologne6 个研究点分布在 1 个国家目标入组 45 人开始时间: 2020年12月14日最近更新: 2024年10月3日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方: University of Cologne
入组人数: 45
试验地点: 6
主要终点: Proportion of Patients With Any AE Within 7 d of Study Drug Administration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is the first-in-human phase 1/2a trial of the inhaled 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-inhalation open-label dose-escalation phase (Groups 1A-1C and Groups 2A-2C). Subsequently, the highest tolerated dose tested 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 both by inhalation and 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-1C
•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 2A-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