66
Participants
Start Date
September 27, 2023
Primary Completion Date
January 3, 2024
Study Completion Date
January 3, 2024
RQ-001
"Drug product RQ-001 is the fully assembled device consisting of the vial containing RQ-01 and the actuator. Drug Product RQ-001 has been developed with an Aptar Bidose liquid nasal spray unit device (BDSI V3) capable of intranasally delivering a 200 uL total volume of drug product (specifically, 100 uL per nare, which delivers a 200 uL of total volume). The combination product comprises the drug constituent (RQ-01) and the assembly of commercially available, off-the-shelf device components.~Study staff will be responsible for assembling the drug product RQ-001 and subjects will self-administer under the supervision of study staff in the clinic."
Placebo
Matching placebo will be manufactured just as RQ-01 drug substance, with the active ingredient addition step omitted. Placebo will appear similar to RQ-01 drug substance as a clear to hazy, colorless to yellowish liquid. Matching placebo will be administered the same way as RQ-01
University of Maryland School of Medicine, Baltimore
Florida International Medical Research, Miami
Zenos Clinical Research, Dallas
Vilo Research Group, L.L.C., Houston
LA Universal Research Center, Inc., Los Angeles
Evergreen Hospital Medical Center, Kirkland
Collaborators (1)
PPD Development, LP
INDUSTRY
Red Queen Therapeutics, Inc.
INDUSTRY