The primary objective of this study is to evaluate the safety and tolerability of intravenous (IV) IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. The secondary objectives of the study are to: * Determine pharmacokinetics (PK) and evaluate viral clearance after single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Day 28. * Evaluate the safety and tolerability, determine PK, and evaluate viral clearance of single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 through Week 12.
This is a randomized, double-blind, placebo-controlled Phase 1 study to evaluate the safety, PK, and viral clearance of single ascending doses of IV IMM-BCP-01 in subjects with mild to moderate COVID-19 caused by infection with SARS-CoV-2 and/or its variants. The study will consist of a screening period of up to 36 hours, a treatment period of one day, two further clinic visits, four visits that will take place either in the clinic or at the subject's home, six virtual visits (telephone or video), and an end-of-study visit 12 weeks (+/- 5 days) after study drug dosing. The total duration of a subject's participation is approximately 90 days. Subjects presenting at the clinic with signs and symptoms of mild to moderate COVID-19 and agreeing to participate in the study will be screened, and if deemed eligible for the study, will be randomized (2:1) to receive a single IV dose of IMM-BCP-01 or placebo on Day 1. Subjects at risk of severe disease and those who have been vaccinated against COVID-19 within 6 weeks prior to screening or who have received monoclonal antibodies against SARS-CoV-2 and/or COVID-19 convalescent plasma at any time will not be eligible. Subjects will be randomized to receive IMM BCP-01 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
9
Single dose of IMM-BCP-01
Placebo matching single dose of IMM-BCP-01
Ark Clinical Research
Long Beach, California, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
TEAEs include clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry
Time frame: Up to 28 days
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
TEAEs include clinical laboratory values, standard 12-lead ECGs, vital signs, pulse oximetry
Time frame: Up to 12 weeks
PK parameters
measured by maximum observed concentration
Time frame: Up to 28 days
PK parameters
measured by time to maximum observed concentration
Time frame: Up to 12 weeks
PK parameters
measured by terminal elimination half-life
Time frame: Up to 12 weeks
PK parameters
measured by clearance
Time frame: Up to 12 weeks
PK parameters
measured by volume of distribution
Time frame: Up to 12 weeks
Anti drug antibody
change from baseline
Time frame: Up to 28 days
Anti drug antibody
change from baseline
Time frame: Up to 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Viral clearance
change from baseline
Time frame: Up to 28 days
Viral clearance
change from baseline
Time frame: Up to 12 weeks