A Phase 1b study of inhaled IN-006 (regdanvimab for nebulization) vs. intravenous regdanvimab
Research type
Research Study
Full title
A Phase 1b, Open-Label, Pharmacokinetics and Safety Study of IN-006 (Regdanvimab for Nebulization) vs. Intravenous Regdanvimab in Healthy Volunteers
IRAS ID
1006745
Contact name
Nichola Routledge
Contact email
Sponsor organisation
Inhalon Biopharma, Inc.
Eudract number
2022-003470-23
ISRCTN Number
ISRCTN90678104
Research summary
COVID-19 is mainly a respiratory illness caused by the virus SARS-COV-2. COVID-19 symptoms generally appear within 14 days of exposure, and commonly include loss of taste or smell, cough, fever, and shortness of breath. Complications of severe COVID-19 in humans with late-stage infection include rapidly progressive lung disease shown by widespread inflammation in the lungs.
The experimental study medication IN-006 (regdanvimab for nebulization) and intravenous regdanvimab are both monoclonal antibodies used to target the COVID-19 virus. An antibody is a protein produced by the body in response to harmful substances (for example bacteria, fungi, parasites and viruses). The antibody in IN-006 and intravenous regdanvimab is a fully human antibody.
Regdanvimab has been found to be effective as a treatment for patients with mild to moderate symptoms of COVID-19 in a clinical trial sponsored by Celltrion. Currently, intravenous regdanvimab is approved for use in the European Union for the treatment of adults with COVID-19 who do not require supplemental oxygen, and who are at increased risk of progressing to severe COVID-19.
The purpose of this research study is to determine whether the study drug, IN-006 (regdanvimab given by nebulization), is safe and well tolerated in healthy participants, and to compare the effects of regdanvimab given intravenously (medication is given in a vein in thearm) vs. IN-006 given via nebulisation (medication is inhaled into the lungs).REC name
South Central - Berkshire Research Ethics Committee
REC reference
22/SC/0437
Date of REC Opinion
5 Apr 2023
REC opinion
Further Information Favourable Opinion