Clinical Trials Phase 1
Clinical trials are series of tests performed on a patient or a volunteer to know about the functionality of a drug before it is introduced into the market. The drug may be found over dosed. This situation is for certain individuals, may not suit minors, or may be allergic for particular group of individuals. All the information and preliminary tests are performed through the clinical trial phase1. The clinical trials are performed after positive information is collected about the safety in using the drug and its quality. The consent and approval of the Health authority/ Ethics committee is required before the tests can be performed on human subjects. Depending on the type of the product and the stages of the product development, the subjects can be chosen. The human subjects can be volunteers, who are average healthy people or even the patients themselves.
Phase 1
A phase 1 clinical trial comprises the preliminary tests performed on a smaller group of human subjects. Here the human subjects taken for the clinical tests are really smaller in amount, i.e. about 20 to 80 persons are considered for the trial. The human subjects are normally healthy volunteers. The phase contains tests that are used to determine the drug tolerance and safety limit of the drug. For example, some drugs on continuous usage they themselves become a burden. Similarly, the tolerance to some drugs may be limited by the human beings. Such features of the drug called the pharmacokinetics and pharmacodynamics are evaluated in the phase 1 tests.
The best place to perform these tests is an inpatient clinic, where there are full time staffs that can monitor the subjects closely. The subjects who have been injected with the drugs are monitored for over several half-life of the drug is completed. The half-life of the material is the time taken for the material to lose half of its activities, which may be physiologic, radioactive, or pharmacologic. Dose ranging of the drug are also included normally in the phase 1 trials. The tested dose ranges are very less and do not cause harm in animal testing. The human subjects sometimes could be the patients themselves. For example, in cancer and HIV drug testing, the patients themselves are volunteered. The sponsors or the pharmaceutical industries pay the volunteers for their inconvenience in time spent for the tests. Pay ranges may vary from smaller amount to huge amount as much as $4000 depending on the time spent.
Kinds of Phase 1 Trials
There are various kinds of phase 1 trials. They are,
SAD:
It stands for Single Ascending Dose. Here in this test, small groups of subjects are given single dose of the drug. If the subjects do not exhibit any adverse effects over a period of time from the drug, then the pharmacokinetics of the drug data are calculated to be on the line. So, the safety limits are within. Then a set of new subjects are given higher dose. This is repeated as long as the safety limit of using the drug is reached or an effect shows up due to intolerance to the drugs. This is the point where the drug has reached its Maximum tolerated dose (MTD).
MAD:
It stands for Multiple Ascending Dose. Here the group of individuals are given multiple dose of the drug and their blood samples and other body fluids are checked for the activity of the dose within the body and they are analyzed. This MAD testing is usually done for better understanding of the pharmacokinetics and pharmacodynamics of the drug. The dose of the drug is increased for small to a maximum amount of predetermined level.
Food Effect:
The varying effect before eating or after eating is tested here. Two healthy subjects are given doses of the drug over a period of time, one while fasting and the other during well fed.
Aims of Phase 1 Trial:
Phase 1 trials are conducted to find out
1. Safe dosage range of the drug tested. This is done by the SAD and MAD tests on the subjects chosen
2. Side effects. Again, with the SAD and MAD tests, the side effects or the adverse effects of the drug can be identified.
3. How the body cope with the new drug. This is very essential. Since, a drug may cure a disease, but it may leave the body vulnerable to other attacks or the drug itself may affect the body.
4. If the treatment has shrunk the occurrence of the disease. The treatment in this phase itself could be enough for shrinking the effects of the disease. Such possibilities are analyzed.
5. The ‘dose escalation study’ is performed with the dose of the drug.
The phase 1 trials are performed on individuals of smaller quantity. The results manipulated are carried over to phase 2 trials investigations are not actually used to identify the perfect working of the drug on the individuals. However, with these phase 1 trials the adverse effects, tolerance limits of the drug is identified and used for performing other tests.
