Trials / Terminated
TerminatedNCT04941183
Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients
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
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Neutrolis · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NTR-441 | NTR-441 |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2021-04-14
- Primary completion
- 2022-12-12
- Completion
- 2023-06-06
- First posted
- 2021-06-28
- Last updated
- 2024-01-19
Locations
4 sites across 2 countries: Austria, Ukraine
Source: ClinicalTrials.gov record NCT04941183. Inclusion in this directory is not an endorsement.