Trial | NCT04631666  Report issue

Title

SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Infusion
A Phase 1/2a Trial of the Intravenous Administration of the SARS-CoV-2-Neutralizing Monoclonal Antibody DZIF-10c in SARS-CoV-2-Infected and -Uninfected Individuals

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    dzif-10c ...

  • Study Participants

    57
This is the first-in-human phase 1/2a trial of the intravenous 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.
The phase 1 component of this trial consists of a single intravenous infusion open-label dose-escalation phase (Groups 1A-1D and Group 2C). Subsequently, the highest tested and tolerated dose 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 by intravenous infusion.
Study Started
Dec 08
2020
Primary Completion
Aug 11
2021
Study Completion
Aug 11
2021
Last Update
Aug 24
2021

Biological DZIF-10c

SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion

Other Placebo

Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo

Group 1A (uninfected) - 2.5 mg/kg Experimental

SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 2.5 mg/kg

Group 1B (uninfected) - 10 mg/kg Experimental

SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 10 mg/kg

Group 1C (uninfected) - 40 mg/kg Experimental

SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg

Group 1D (uninfected) - high dose Experimental

SARS-CoV-2-uninfected volunteers will receive a single intravenous infusion of DZIF-10c at a dose higher than 40 mg/kg

Group 2C (infected) - 40 mg/kg Experimental

SARS-CoV-2-infected volunteers will receive a single intravenous infusion of DZIF-10c at a dose of 40 mg/kg

Group 2D (infected) - 40 mg/kg Experimental

SARS-CoV-2-infected volunteers will be randomized 2:1 to receive an intravenous infusion of DZIF-10c at a dose of 40 mg/kg or placebo

Criteria 

Inclusion Criteria:

Groups 1A-1D

Age 18-65.
SARS-CoV-2-RNA negative naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
Non-reactivity of serum antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.

Groups 2C-2D

Age 18-70.
SARS-CoV-2-RNA positive naso- or oropharyngeal swab obtained within 3 calendar days before study drug administration by NAAT (e.g., qRT-PCR).
Onset of COVID-19 symptoms (e.g., sore throat, cough, fever, chills, fatigue, dys- or anosmia, dys- or ageusia, headache, muscle pain, gastrointestinal symptoms) within 7 days prior to study drug administration or Non-reactivity of serum or plasma antibodies (IgG; and IgA and/or IgM when tested) against SARS-CoV-2 by serological assay at screening.
Disease severity score 1-4 as defined by the WHO Clinical Progression Scale (WHO, Lancet Inf Dis 2020).

Exclusion Criteria (all groups):

Known hypersensitivity to any constituent of the investigational medicinal product.
Hepatitis B infection indicated by detectable HBsAg (Hepatitis B surface antigen) in blood.
Detectable antibodies against hepatitis C virus in blood unless active hepatitis C is ruled out by negative HCV-RNA.
HIV infection indicated by detectable HIV antigen and/or HIV antibodies in blood.
Neutrophil count ≤1,000 cells/µl
Hemoglobin ≤10 g/dl
Platelet count ≤100,000 cells/µl
ALT ≥2.0 x ULN
AST ≥2.0 x ULN
Total bilirubin ≥1.5 ULN
eGFR <60 ml/min/1.73m2
Pregnancy or lactation.
Any vaccination within 14 days prior to DZIF-10c administration.
Receipt of any SARS-CoV-2 vaccine or SARS-CoV-2 monoclonal antibody in the past.
Diagnosis of bronchial asthma or history of bronchial hyperresponsiveness, COPD, pulmonary fibrosis, or other chronic lung diseases.
Any chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the volunteer.
History of systemic corticosteroids, immunosuppressive anti-cancer, or other medications considered significant by the trial physician within the last 6 months (a single administration of systemic corticosteroids within ≤6 months and ≥4 weeks of enrollment is acceptable).
Participation in another clinical trial of an investigational medicinal product within the past 12 weeks or expected participation during this study.
Dependency on the principal investigator or study staff; or site personnel directly affiliated with this trial.
Legally incapacitated individuals
Individuals held in an institution by legal or official order
If engaging in sexual activity that could result in pregnancy, inability or unwillingness to comply with the requirements for highly effective contraception
No Results Posted