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 site in 1 country23 target enrollmentJanuary 11, 2021

ConditionsCovid19

InterventionsC144-LS and C-135-LS

DrugsC144-LS and C-135-LS

Overview

Phase: Phase 1
Intervention: C144-LS and C-135-LS
Conditions: Covid19
Sponsor: Rockefeller University
Enrollment: 23
Locations: 1
Primary Endpoint: Grade 2 and Higher Adverse Events 4 Weeks After Administration.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein in healthy volunteers.

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 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).

Registry

clinicaltrials.gov

Start Date

January 11, 2021

End Date

February 2, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Rockefeller University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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;