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

NCT04631705 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2024-10-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • ZKS Köln

    collaborator OTHER

  • Boehringer Ingelheim

    collaborator INDUSTRY

  • University of Cologne

    lead OTHER

Principal Investigators

  • Gerd Fätkenheuer, MD · University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-12-14
Primary Completion
2021-09-23
Completion
2021-09-23

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT04631705 on ClinicalTrials.gov