FIRST-IN-HUMAN
Spaulding: Where First-In-Human Begins
The first dose in humans is a critical step
Spaulding Clinical brings the experience, infrastructure, and scientific expertise to help move your development forward-safely, efficiently, and with confidence.
FIH EXPERIENCE YOU CAN MEASURE
First-In-Human studies require careful coordination across clinical operations, medical oversight, recruitment, safety, data management, and biometrics. Spaulding brings those capabilities together to help sponsors make critical early-development decisions with confidence.
| FIH Number of Participants Enrolled | 743 |
| FIH Participant Retention | 98.3% |
| FIH Combined Senior Leadership Experience (Includes Medical Director with 22 years) | 132 years |
| Clinic Coverage of ACLS Certified Staff | 24/7 |
| Distance to Local Emergency Room | 5.3 miles |
FIH IN ACTION
Spaulding Clinical conducted the First-In-Human study of a frontline on-demand plasma product, a spray dried plasma product designed for use beyond traditional hospital settings.
- 24 healthy volunteers
- Dose escalation up to 800 mL
- All infusions well tolerated
- No thromboembolic events observe
The results of this First-In-Human study were published in Transfusion. Read the full publication to dive deeper into the study design, results, and conclusions. Image and article courtesy of Transfusion.org.