phase 1 study to assess safety, tolerability, pd, pk, immunogenicity of iv ntr-441 solution in healthy volunteers and covid-19 patients

Conditions: Covid19

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.


Eligibility 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. exclusion criteria: * pregnancy, nursing, and/or breastfeeding. * history of an anaphylactic reaction. * in the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. * severely immune-compromised participants. * participant known to test positive for human immunodeficiency virus (hiv), chronic or active hepatitis b, or active hepatitis c. * any other clinical conditions that in the opinion of the investigator would make the participants unsuitable for the study. * prior treatment with any investigational drug therapy against coronavirus infection within 5 half-lives, prior to enrollment * participants who have received an experimental (or, in future, potentially a licensed) immunization or remdesivir against coronavirus remain eligible. * participation in another clinical study with the study intervention administered from 30 days or 5 half-lives whichever is longer. * anticipated transfer to another hospital which is not a study site during the intervention period.

Keywords: covid 19