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

NCT ID: NCT04941183

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-14
• Study Completion Date: 2023-06-06

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

NTR-441

Single Ascending Dose; Multiple Ascending Dose.

Group Type: EXPERIMENTAL

NTR-441

Intervention Type: DRUG

NTR-441

Placebo

Single Ascending Dose; Multiple Ascending Dose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Interventions

NTR-441

NTR-441

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Eligibility Criteria

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.

• 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.
• Subject has hypertension.

COVID-19 patients:

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neutrolis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Austria; Ukraine

Other Identifiers

NTR441-1001

Identifier Type: -

Identifier Source: org_study_id