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

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.

Timeline

Start

2021-04-14

Primary completion

2022-12-12

Completion

2023-06-06

Outcome

Outcome not reported

Stopped (Enrollment): “the emergence of the omicron variant of COVID-19 lead to insufficient enrollment”

Drugs

Indications