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.
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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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
The Rockefeller University
New York, New York, United States
Grade 2 and Higher Adverse Events 4 Weeks After Administration.
The number of participants with treatment-related solicited and unsolicited grade 2 adverse events (including confirmed laboratory abnormalities).
Time frame: 4 weeks
Grade 3 and Higher Adverse Events 4 Weeks After Administration.
The number of participants with treatment-related solicited and unsolicited grade 3 adverse events (including confirmed laboratory abnormalities).
Time frame: 4 weeks
Related Serious Adverse Events (SAEs) Throughout the Study Period
The number of participants with treatment-related solicited serious adverse events.
Time frame: 48 weeks
Elimination Half-life (t1/2) of C135-LS and C144-LS
Half-life of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Time frame: 48 weeks
Clearance Rate of C135-LS and C144-LS
Clearance rate of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Time frame: 48 weeks
Area Under the Curve of C135-LS and C144-LS
Area under the curve of C135-LS and C144-LS when administered intravenously or subcutaneously in healthy volunteers
Time frame: 48 weeks
Investigational Product (IP)-Related Adverse Events During Study Follow up.
The number of participants with treatment-related adverse events
Time frame: 48 weeks
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Anti-C144-LS and Anti-C135-LS Antibodies in All Study Groups.
Proportion of individuals with treatment-induced anti-drug antibodies against each mAb and magnitude of the response
Time frame: 48 weeks