RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers

Completed · Phase 1

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04700163

Run by

Rockefeller University

People needed

23

Starts

2021-01-11

Expected to finish

2022-02-02

Last updated by the study team

2025-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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-19.
• 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.

Where it is running

• The Rockefeller University — New York, New York, United States

Full record on ClinicalTrials.gov

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