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

Neutrolis4 sites in 2 countries52 target enrollmentApril 14, 2021

ConditionsCovid19

InterventionsNTR-441 Placebo

DrugsNTR-441 Placebo

Overview

Phase: Phase 1
Intervention: NTR-441
Conditions: Covid19
Sponsor: Neutrolis
Enrollment: 52
Locations: 4
Primary Endpoint: To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 14, 2021

End Date

June 6, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Neutrolis

Responsible Party

Sponsor

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.

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.

Arms & Interventions

NTR-441

Single Ascending Dose; Multiple Ascending Dose.

Intervention: NTR-441

Placebo

Single Ascending Dose; Multiple Ascending Dose.

Intervention: Placebo

Outcomes

Primary Outcomes

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

Time Frame: 60 days

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

Secondary Outcomes

To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults(30 days)
Measurement of terminal elimination half-life (t½)(15 days)
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 total body clearance (CL/F)(15 days)
Measurement of apparent volume of distribution(15 days)