NanoViricides Inc (NNVC)

[loanranger]

"Would be good to see the trial endpoints besides safety, plus the size of the study, duration, etc... I imagine this will be a small, short safety trial, possibly with ascending doses? Likely to be randomized and placebo controlled? "

https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=67454&EncHid=&userName=Karveer Meditech
Registered on: 18/04/2023
Date of First Enrollment (India) 01/05/2023
Estimated Duration of Trial Years="0"Months="1"Days="5"
Total Sample Size="72"
Randomized, no comparator....I take that to mean no placebo..
Secondary Outcome
To evaluate the Pharmacokinetic (for healthy subjects only) and Pharmacodynamic nature (for Covid-19 patients only) of NV-CoV-2.
- To obtain an early measurement of drug activity in mild/moderate COVID-19 patients.

From the press release:
"The Single Dosing of Healthy Volunteers portion of the Phase 1a began with the dosing of a first set of volunteers on June 17, 2023. This set of volunteers was successfully discharged after a 48 hours in-hospital stay for observation, and will be further assessed in a final out-person visit as per the protocol. Further recruitments and dosings are scheduled as per the protocol."

How long do you think it would take to assess safety before dosing the 1b patients?

Why did it apparently take 5 months to scrape together 36 healthy volunteers? Been a long time coming.....seems a little patience is finally justifiable but I'm itching to see where this goes.