First In Human Clinical Research Capabilities
First-in-Human trials are a key step in the drug development process. This is the first opportunity for drug developers to observe or “translate” all the observations from preclinical testing into human subjects. Participants in these trials, typically healthy volunteers, face an element of risk as the ability of researchers to predict the effects of a new medicine on people is limited before it has been studied in humans. Therefore, these trials are best conducted by an organization that understands the risks associated and keeps the safety and well-being of subjects as a first priority when designing and executing the studies.
Since 2005, WCCT has conducted over 140 First-in-Human trials at our clinical pharmacology unit in Cypress, CA. Of these, 17 have resulted in FDA-approved drugs, and 13 more are currently being developed in late stage trials.
Early development (First-in-Human) protocols have become increasingly complex over the past several years. Single and Multiple Ascending Dose protocols often include multiple objectives:
- Safety and Tolerance
- Pharmacodynamics (early indicators of “on-target” or “ off-target” activity relative to drug exposure utilizing specific biomarkers)
- Food effect
- Participant age, gender, or ethnicity
- Potential interactions with expected co-therapies
- Therapeutic outcome in a small panel of patients suffering the targeted illness
WCCT can help you evaluate or determine:
- Starting Dose/Maximum Recommended Starting Dose (MRSD)
- Dose escalation strategy
- Strategies for using biomarkers to assess potential on-target and off-target activities of your compound
- “Ethnic sensitivity” at the targeted therapeutic level or at all doses tested
- Potential Drug to Drug Interactions or the effect of food
WCCT Advantages for First-in-Human Studies
In-House scientific and medical writing personnel
Supports protocol development and creates clear stopping rules and terms for safety review meetings
Internal Safety Review Committee
Ensures smooth progression between cohorts as doses are increased
In-House Safety Reference Laboratory
Allows PK/Safety results to be available in under 24hrs. to inform dose escalation decisions
Ability to obtain data from biomarker evaluation
Enhances “go/no-go” decisions by determining if specific targets are reached
Robust volunteer database of over 55,000
Expedites enrollment timelines, provides access to best-fit subject population
Sample Experience List
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Case study on First-In-Human trial in a special population.
Early Clinical Development
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