This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
52
Klinik Favoriten
Vienna, Austria
Medical University Vienna, Department of Clinical Pharmacology
Vienna, Austria
Kyiv City Clinical Hospital#1
Kyiv, Ukraine
Vinnytsa City Clinical Hospital # 1
Vinnytsia, Ukraine
To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441.
Time frame: 60 days
Measurement of maximum plasma concentration (Cmax)
Maximum plasma concentration
Time frame: 15 days
Measurement of time of maximum plasma concentration (Tmax)
Time of maximum plasma concentration
Time frame: 14 days
Measurement of area under the concentration-time curve
Area under the concentration-time curve from predose to the time of the last quantifiable concentration
Time frame: 15 days
Measurement of the terminal elimination rate (λz)
Terminal elimination rate
Time frame: 15 days
Measurement of terminal elimination half-life (t½)
Terminal elimination half-life
Time frame: 15 days
Measurement of total body clearance (CL/F)
Total body clearance
Time frame: 15 days
Measurement of apparent volume of distribution
Apparent volume of distribution
Time frame: 15 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults
Concentration of anti-drug antibodies of NTR-441 following single and multiples doses of NTR-441 solution administered IV
Time frame: 30 days