ILNS sponsered a phase Ia trial in healthy human and Shire a phase Ib in FA.
Phase 1:
the initial phase of testing of an investigational drug in humans. Usually a
Phase 1 clinical study is conducted in a small number of healthy volunteers or patients
with a disease for which the drug may be useful. Generally, the study is designed to
determine the side effects of the drug and its pharmacokinetics. Some information
regarding drug efficacy may be collected if patients with a disease participate. A phase
frequently encompasses more than one clinical trial. Phase 1 sometimes is sub-divided
into Phases 1a and 1b, for example when the first set of Phase 1 trials (Phase 1a) is
performed in healthy volunteers and a second set of Phase 1 trials (Phase 1b) is
performed in patients with a disease.
Phase 2:
the intermediate phase of testing of an investigational drug in humans. Usually
a Phase 2 clinical study conducted in patients with a disease for which the drug may be
useful. Generally, the study is designed to evaluate dosing, to obtain preliminary data on
the effectiveness of the drug, and to acquire more safety information. Phase 2 sometimes
is sub-divided into Phases 2a and 2b. Phase 2a studies typically are smaller and shorter
in duration and evaluate different drug doses to see how they affect certain tests that can
indicate whether the drug is working as expected. Phase 2b studies typically enroll more
patients, are of longer duration and evaluate whether the drug is offering clinical benefits
to patients. Phase 2b studies sometimes are considered pivotal or registration-directed.
Phase 3:
the final phase of testing an investigational drug in humans before regulatory
approval. Phase 3 studies are usually conducted in a large population of patients and are
generally designed to confirm the effectiveness of the drug and to evaluate the overall
risk-benefit ratio. Phase 3 studies usually test the investigational drug in comparison with
a standard treatment for the disease or a placebo.
Phase 4:
testing of a drug in humans after it has already been approved by regulatory
authorities and can be used in medical practice. Phase 4 studies may be conducted to
compare the drug to a similar type of drug, to explore whether it may help patients with
other diseases, to further study the long-term safety of the drug, or for other reasons.
You bore me to death, it's time to hit the ignore button
Things that are equal to the same thing are also equal to one another (Transitive property of equality). If equals are added to equals, then the wholes are equal. If equals are subtracted from equals, then the remainders are equal. Things that coincide wi
