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Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE1

Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients

A Randomized, Placebo-controlled, Double-blind, Single-ascending-dose and Multiple-ascending-dose, Phase 1 Study to Assess the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of IV NTR-441 Solution in HV Adults and COVID-19 Patients

NCT04941183•Neutrolis

View on ClinicalTrials.gov

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

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy volunteers:
•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.
•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.
•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.
+12 more criteria

Locations (4)

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

Key Dates

Start Date

April 14, 2021

Primary Completion Date

December 12, 2022

Completion Date

June 6, 2023

Last Updated

January 19, 2024

Enrollment

ACTUAL participants

Conditions

Covid19

Interventions

NTR-441

DRUG

Placebo

DRUG

The Effect of the Covid-19 Pandemic Among Operated Patients

NCT04525716

Covid19Surgery

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RECRUITINGPHASE3

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

NCT03188796

Critical IllnessVitamin D Deficiency+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients

Inclusion Criteria

Exclusion Criteria

The Effect of the Covid-19 Pandemic Among Operated Patients

The VITDALIZE Study: Effect of High-dose Vitamin D3 on 28-day Mortality in Adult Critically Ill Patients

Covid-19 and Influenza Oral Vaccine Study

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