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

NCT04941183 | Terminated Phase 1 DMC

• 1 other identifier: NTR441-1001
• Study Type: interventional
• Target: 52
• Locations: 2 countries
• Sites: 4

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

Keywords

Covid 19

Outcome Measures

Primary Outcomes (1)

• To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults

  Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441.

  60 days

Secondary Outcomes (8)

• Measurement of maximum plasma concentration (Cmax)

  15 days

• Measurement of time of maximum plasma concentration (Tmax)

  14 days

• Measurement of area under the concentration-time curve

  15 days

• Measurement of the terminal elimination rate (λz)

  15 days

• Measurement of terminal elimination half-life (t½)

  15 days

Study Arms (2)

NTR-441

EXPERIMENTAL

Single Ascending Dose; Multiple Ascending Dose.

Drug: NTR-441

Placebo

PLACEBO COMPARATOR

Single Ascending Dose; Multiple Ascending Dose.

Drug: Placebo

Interventions

NTR-441 DRUG

NTR-441

NTR-441

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Neutrolis: lead

Study Sites (4)

Klinik Favoriten

Vienna, Austria

Location

Medical University Vienna, Department of Clinical Pharmacology

Vienna, Austria

Location

Kyiv City Clinical Hospital#1

Kyiv, Ukraine

Location

Vinnytsa City Clinical Hospital # 1

Vinnytsia, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

NTR-441

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, placebo-controlled, double-blind, single-ascending-dose and multiple-ascending-dose

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: June 28, 2021
• Study Start: April 14, 2021
• Primary Completion: December 12, 2022
• Study Completion: June 6, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

UA (2); AU (2)