A Phase 1, Open Label, Dose-escalation Study of the Safety and Pharmacokinetics of a Combination of Two Anti-SARS-CoV-2 mAbs (C144-LS and C135-LS) in Healthy Volunteers

Rockefeller University1 个研究点分布在 1 个国家目标入组 23 人开始时间: 2021年1月11日最近更新: 2025年3月13日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Rockefeller University
入组人数: 23
试验地点: 1
主要终点: Grade 2 and Higher Adverse Events 4 Weeks After 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 a first-in-human, open label, single dose, dose-escalation phase 1 study to evaluate the safety and pharmacokinetics of a combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy volunteers.

详细描述

The study has a standard 3+3 phase 1 dose escalation design. Study participants will receive subcutaneous injections of C144-LS and C135-LS at 4ml (approximately 100mg of each antibody administered separately) or 8ml (approximately 200mg of each antibody administered separately), or sequential intravenous infusions of C144-LS and C135-LS, at one of three increasing dose levels (1.5 mg/kg, 5 mg/kg and 15 mg/kg of each antibody).

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Aged 18 or older.
•If sexually active male or female, and participating in sexual activity that could lead to pregnancy, agrees to use one effective method of contraception from 10 days prior to the antibody administration until 6 months after investigational product (IP) administration.

排除标准

•Weight > 110 kg for groups S1 and S2 only
•History of prior positive SARS-CoV-2 RT-PCR or SARS-CoV-2 serology.
•Active respiratory or non-respiratory symptoms consistent with COVID-
•Medically attended acute illness or hospitalization (ie, >24 hours) for any reason within 30 days prior to screening.
•Acute exacerbation of a chronic pulmonary condition (eg, chronic obstructive pulmonary disease [COPD], asthma exacerbations, or uncontrolled hypertension, as defined by a systolic blood pressure > 180 and/or diastolic blood pressure > 120, in the presence or absence of anti-hypertensive medications) in the past 6 months prior to screening.
•Use of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months.
•Other clinically significant acute or chronic medical condition that in the opinion of the investigator would preclude participation.
•Laboratory abnormalities in the parameters listed:
•Absolute neutrophil count less than 1,500 K/mcL;
•Hemoglobin less than 10.5 gm/dL if female; less than 11 gm/dL if male;
•Platelet count less than 125,000 K/mcL;
•ALT less than 1.25 x ULN; AST less than 1.25 x ULN;
•Total bilirubin less than 1.25 x ULN;
•Creatinine less than 1.1 x ULN;
•Pregnancy or lactation.
•Any vaccination within 14 days prior to SARS-CoV-2 mAbs administration (except influenza vaccine).
•History of prior receipt of any SARS-CoV-2 vaccine or antibodies, including convalescent plasma.
•Known allergy/sensitivity or any hypersensitivity to components of the investigational agents.
•History of severe reaction to a vaccine or monoclonal antibody administration or history of severe allergic reactions.
•Participation in another clinical study of an investigational product currently or within past 12 weeks, or expected participation during this study.