Phase I trials mostly are focused on 'safety' profiles and in testing out different dosages, so yeah - I think that's going to be the primary goal here as well. But some inkling of what other sorts of data they intend to collect and how they plan to use that data to (hopefully) design a more extensive Phase II would be nice to see ahead of time.
Hopefully just getting a Phase I trial going in India will be enough to 'goose' the share prices enough that we won't get as big of a dilution for existing shareholders, or that that's enough to encourage a trial partnership with some other bigger pharma for the herpes-cides.
I think your take here is correct KMBJN. I am cautiously optimistic that we might finally start to see something moving after way too many years of bupkis.
"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.