Status:
COMPLETED
RU Anti-SARS-CoV-2 (COVID-19) mAbs in Healthy Volunteers
Lead Sponsor:
Rockefeller University
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 se...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 11 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2022
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04700163
Start Date
January 11 2021
End Date
February 2 2022
Last Update
March 13 2025
Active Locations (1)
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1
The Rockefeller University
New York, New York, United States, 10065