Phase 2a RSV Human Challenge Study of MK-1654 in Healthy Participants
Research type
Research Study
Full title
A Phase 2a Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-1654 in Healthy Participants Inoculated with Experimental Respiratory Syncytial Virus.
IRAS ID
262306
Contact name
Mariya Kalinova
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp
Eudract number
2018-003347-28
Duration of Study in the UK
0 years, 4 months, 9 days
Research summary
The purpose of this study is to determine whether the study drug (MK-1654) is effective in preventing Respiratory Syncytial Virus (RSV) in healthy adults.
The drug being tested in this study is MK-1654, a prophylactic (protective) human monoclonal antibody (mAb) which targets RSV F protein and is designed to reduce the quantity of the virus in the nose and lungs. If the study drug is found to be effective, the results will provide proof that MK-1654 can reduce symptomatic RSV infection in adults. The findings from this study could potentially support preventative approaches to RSV in both adults and infant populations.
This study will recruit healthy adult volunteers aged 18-55. Approximately 80 participants will be enrolled and dosed with MK-1654 and up to 70 participants will be given the RSV virus and are expected to complete the study. The study will last approximately 21 weeks and each participant will remain in the study for approximately 13 weeks. Participants will undergo other procedures during the study as outlined in the schedule of assessments.
This study will include the following phases: Screening, Treatment (participants will receive intravenous (IV) MK-1654 (100mg, 200mg, 300mg or 900mg) or placebo), Viral challenge (participants will be admitted for a 14 day / 13 night in the study clinic and inoculated with experimental RSV strain RSV A Memphis 37b), and Follow-up.
This study is funded by Merck, Sharpe and Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD).REC name
HSC REC B
REC reference
19/NI/0171
Date of REC Opinion
3 Oct 2019
REC opinion
Further Information Favourable Opinion