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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

NCT04941183 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-01-19

No results posted yet for this study

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

Interventions

DRUG

NTR-441

NTR-441

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Neutrolis

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-12-12
Completion
2023-06-06

Countries

  • Austria
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941183 on ClinicalTrials.gov