Phase I Clinical Trial - is the first test of a new drug in humans, usually involving 20-80 healthy volunteers, during which the researchers set a range of doses within which the drug is fairly well tolerated with a single or repeated administration.
In some cases (depending on the pharmacological group of new drug) Phase I trial are carried out with the participation of patients with severe diseases of various etiologies.
CDC of NUPh has more than 20 years of experience in conducting Phase I clinical trial, in which participants were:
- healthy volunteers,
- patients (Rheumatoid arthritis, liver cirrhosis, Parkinson's disease).
In average the duration of the Phase I clinical study is from 6 months to 1 year, at which about 1/3 candidate substances are screened due to their poor tolerance or poor absorption.
The main goal of the studies of this stage is to determine the necessity of continuing work on a new drug.
CDC of NUPh also conducted FIH (first-in-human) trial.
The team of CDC of NUPh has experience in conducting Phase I CT with dose escalation. At CDC of NUPh, CT (Phase I) of various dosage forms with different routes of administration (oral, transdermal, intramuscular and intravenous), including administration of medication infusion for 36 hours were conducted.
During the study, volunteers or patients are under round-the-clock supervision of medical staff of CDC of NUPh.
All research procedures are recorded using video surveillance cameras installed throughout the territory of the CDC.
All clinical study are conducted according to ICH GCP requirements.
Useful link:Phase I, II, IV Clinical Trial