Phase 0 Clinical trial in pharma:
Phase 0 clinical trial is the initial stage of the clinical trial. The development of a drug for a specific disease condition involves several stages of testing in animal models before it is tested on select human volunteers. Phase 0 trials use a small number of human volunteers for testing a proposed drug.
This phase is intended to streamline and speed up the approval process for drugs. Researchers may be able to learn more about the drugs’ effectiveness through phase 0 studies. By doing this, we may be able to save time and money that would have otherwise been spent on trials in the later phases.
We can say, the first human clinical trial of the new untested drug is a phase 0 clinical trial.
Volunteers for this phase are very few, usually between 10 and 12 people, due to the unknown risks posed by the new drug.
A healthy volunteer is usually chosen for early testing rather than an individual with a condition the drug is intended to treat.
In order to minimize any adverse side effects that exposure to the drug might cause, very small amounts of the drug are used for minimal durations of less than seven days. A low dose of the drug was found to be nontoxic in animal studies.
Candidate drugs are also ranked in Phase 0 trials to determine which should proceed to Phase I trials. Human studies may be more reliable than animal studies when it comes to making such decisions during phase 0 trials. A safe dosing regimen is established through escalating dose testing of drugs that proceed to Phase 1 trials.
It is also known as a Proof-of-Concept trial or a Pre-phase 1 trial. Trials of new drugs require a Phase 0 clinical trial in order to increase safety and effectiveness.
Purpose of phase 0 clinical trial:
This phase is intended to streamline and speed up the approval process for drugs. Researchers may be able to learn more about the drugs’ effectiveness through phase 0 clinical studies. By doing this, we may be able to save time and money that would have otherwise been spent on trials in the later phases.
This phase focuses not on testing the therapeutic effects of the drug but on checking that it behaves as expected in humans and gathering preliminary information about what the drug does to the body and how the body responds.
- Preclinical Development wikipedia
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Refer YT Channel: Pharmabeej