Propanc Biopharma Inc (PPCB)

[elkhunter]

Agreed, Phase 1 trials should have started by now. Nathanielsz reluctance to have PRP tested and evaluated on humans raises concerns that it might not be safe to administer. Phase 1 trials is only to determine the safety, possible side effects, and highest tolerance level that can be safely administered. Something is amiss.

Phase I studies of a new drug are usually the first that involve people. Phase I studies are done to find the highest dose of the new treatment that can be given safely without causing severe side effects. Although the treatment has been tested in lab and animal studies, the side effects in people can’t be known for sure. These studies also help to decide on the best way to give the new treatment.
Key points of phase I clinical trials

The first few people in the study get a very low dose of the treatment and are watched very closely. If there are only minor side effects, the next few participants get a higher dose. This process continues until doctors find a dose that’s most likely to work while having an acceptable level of side effects.
Phase I trials are also looking at what the drug does to the body and what the body does with the drug.
Safety is the main concern. The research team keeps a close eye on the people and watches for any severe side effects. Because of the small numbers of people in phase I studies, rare side effects may not be seen until later phases of trials when more people receive the treatment.
While some people may benefit from being on one, disease response is not the main purpose of a phase I trial,
Placebos (inactive treatments) are not used in phase I trials.
Phase I trials usually include a small number of people (up to a few dozen).
Phase I trials most often include people with different types of cancer.
These studies are usually done in major cancer centers.

Phase I trials carry the most potential risk. But phase I studies do help some patients. For those with life-threatening illnesses, weighing the potential risks and benefits carefully is key. Sometimes people choose to join phase I trials when all other treatment options have already been tried.