The company Neutrolis is enrolling patients into the clinical trial investigating Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients.
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.
The trial is designed to enroll male and female 18 Years to 99 Years and is being conducted in the Medical University of Vienna, Department of Infectiology and Tropical Medicine, Vienna, Austria; Medical University Vienna, Department of Clinical Pharmacology, Vienna, Austria.
The study start date is April 14, 2021.
The patients that can be enrolled into this study include:
- 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.
- 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.
This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04941183.