Covid19
Conditions
Keywords
Covid 19
Brief summary
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.
Interventions
DRUGNTR-441
NTR-441
DRUGPlacebo
Placebo
Sponsors
Neutrolis
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy volunteers: Inclusion Criteria: * Male or female, non-smoker, ≥18 and ≤55 years of age, with Body Mass Index (BMI) \> 18.5 and \< 32.0 kg/m2 * Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening * Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff. * Subject voluntarily agrees to participate in this study.
Exclusion criteria
* Pregnancy, nursing, and/or breastfeeding. * Study participant has a history of an anaphylactic reaction. * Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug. * Has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer. * Subject has a positive urine test for drugs of abuse at the screening visit or admission. * Regular consumption of alcohol within 6 months prior to Screening or use of illicit substances within 3 months prior to screening. * Subject has positive test for SARS-CoV-2 infection, human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C. * Donation or loss of blood or plasma within 4 weeks prior to initial dosing. * Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy; a history of a psychiatric disorder that will affect the subject's ability to participate in the study. * Subject has a clinically relevant abnormal ECG; abnormal laboratory values. * Subject has hypertension. COVID-19 patients: Inclusion Criteria: * Male or female, non-smoker, ≥18 years of age. * Participant has active laboratory-confirmed SARS-CoV-2 infection. * Participant must be hospitalized for COVID-19 pneumonia. * Ability to provide informed consent personally, or by a legally acceptable representative if the participant is unable to do so.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults | 60 days | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of time of maximum plasma concentration (Tmax) | 14 days | Time of maximum plasma concentration |
| Measurement of area under the concentration-time curve | 15 days | Area under the concentration-time curve from predose to the time of the last quantifiable concentration |
| Measurement of the terminal elimination rate (λz) | 15 days | Terminal elimination rate |
| Measurement of maximum plasma concentration (Cmax) | 15 days | Maximum plasma concentration |
| Measurement of total body clearance (CL/F) | 15 days | Total body clearance |
| Measurement of apparent volume of distribution | 15 days | Apparent volume of distribution |
| To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults | 30 days | Concentration of anti-drug antibodies of NTR-441 following single and multiples doses of NTR-441 solution administered IV |
| Measurement of terminal elimination half-life (t½) | 15 days | Terminal elimination half-life |
Countries
Austria, Ukraine
Outcome results
None listed