Phase I trials
Smooth Drug Development offers services for phase I studies (first in human).
Phase I studies are conducted after the drug has shown sufficient efficacy and safety studies in vitro and in vivo. Usually these studies are conducted in healthy volunteers, however, toxic agents and biological drugs are tested in patients with relevant diseases. In phase I safety, tolerability, pharmacokinetic and pharmacodynamic parameters are tested. Sometimes these studies are divided into research phase Ia and Ib according to the primary target.
In general, to obtain regulatory approval the following documents are required:
- Information on the composition of the drug
- Certificate of Analysis
- Pre-clinical reports
- Clinical development program
- Investigator's Brochure
- Clinical Study Protocol
- Information for subject and Informed Consent Form
- Information on payments and compensation for subjects
- Other materials for subjects
- Insurance agreement for study subjects
- List of investigational sites and CVs of principal investigators
- Confirmation of application fees
Our team has experience in various types of phase I studies:
- In healthy volunteers to study PK and PD and bioavailability
- In healthy men and women
- On special populations
- In patients with different diseases
- Different ways of administration/different dosage forms
- Food influence (fasted/fed)
- Age/gender influence
- Drug, or alcohol interactions
We fully understand difficulties connected with phase I study conduct:
- Intense PK and PD
- Utilization of complex laboratory methods, requiring trained of site personnel
- Site selection and enrolment challenges
- Safety challenges
- Ethical, scientific and regulatory challenges
Our team works with specialized phase I units performing clinical trials in patients and healthy subjects.