NCT04631705

SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation

A Phase 1/2a Trial of the Inhaled Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals. It will evaluate the safety, pharmacokinetic profile, immunogenicity, and antiviral activity of DZIF-10c.

Detailed description

The phase 1 component of this trial consists of a single-inhalation open-label dose-escalation phase (Groups 1A-1C and Groups 2A-2C). Subsequently, the highest tolerated dose tested will be administered to an expansion cohort of SARS-CoV-2-infected individuals (Group 2D). In this randomized and blinded group, participants will receive DZIF-10c or placebo both by inhalation and intravenous infusion.

Conditions

• SARS-CoV-2 Infection

Interventions

Type	Name	Description
BIOLOGICAL	DZIF-10c	Inhaled administration of the human monoclonal antibody DZIF-10c
BIOLOGICAL	DZIF-10c	Intravenous administration of the human monoclonal antibody DZIF-10c
DRUG	Placebo	Inhalation of DZIF-10c diluent as placebo
DRUG	Placebo	Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo

Timeline

• Start date: 2020-12-14
• Primary completion: 2021-09-23
• Completion: 2021-09-23
• First posted: 2020-11-17
• Last updated: 2024-10-03
• Results posted: 2024-10-03

Locations

6 sites across 1 country: Germany