This study will investigate how ensovibep is distributed throughout the body, the safety and the tolerability of ensovibep in healthy volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
53
The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.
One administration at day 1 by infusion.
HMR
London, United Kingdom
Vital Signs: Blood Pressure Systolic and Diastolic (mmHg)
Time frame: up to day 100 (EOS)
Vital Signs: Heart Rate (bmp)
Time frame: up to day 100 (EOS)
Vital Signs: Tympanic Temperature (°C)
Time frame: up to day 100 (EOS)
Vital Signs: Oxygen Saturation (SpO2%)
Time frame: up to day 100 (EOS)
Cardiac Safety assessed by 12-lead Electrocardiogram (ECG)
Time frame: up to day 100 (EOS)
Physical Examination
For safety purpose, the following will be examined during full physical examinations: general appearance; head, ears, eyes, nose and throat; thyroid; lymph nodes; back and neck; heart; chest; lungs; abdomen; skin; and extremities; and the following systems will be assessed: musculoskeletal and neurological.
Time frame: up to day 100 (EOS)
Number of subjects with Laboratory Abnormalities
Time frame: up to day 100 (EOS)
Assessment of local tolerability
Number of subjects with reaction at the injection site. The injection site is assessed for any pain, tenderness, erythema and induration.
Time frame: up to day 100 (EOS)
Number of subjects with Adverse Events
Time frame: up to day 100 (EOS)
Observed maximum concentration (Cmax)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The maximum observed concentration (Cmax) is estimated based on the serum concentrations.
Time frame: up to day 100 (EOS)
Time to Cmax (Tmax)
Time frame: up to day 100 (EOS)
The area under the serum concentration-time curve (AUC)
Time frame: up to day 100 (EOS)
Apparent total body clearance of the drug from plasma (CL)
Time frame: up to day 100 (EOS)
The apparent volume of distribution during terminal phase after drug administration (Vz)
Time frame: up to day 100 (EOS)
Terminal Elimination Half-Life (T½)
Time frame: up to day 100 (EOS)
Proportion of subjects with treatment-emergent anti-drug antibodies (ADA)
Time frame: up to day 100 (EOS)