First-in-Human, SAD & MAD Studies
First-in-Human, SAD & MAD Studies – Porto, Portugal
Safety First. Science Forward.
At Astrum, First-in-Human (FIH) and dose-escalation studies are conducted in our 60-bed hospital-based Phase I unit in Porto — one of Europe’s largest and most advanced facilities. With direct ICU and emergency access, EMA/FDA/ANVISA Inspections, and decades of experience, Sponsors can trust us to deliver both safety and speed at this critical milestone.
Why FIH & SAD/MAD Matter
FIH trials
FIH trials establish initial human safety, tolerability, and PK/PD.
SAD studies
SAD studies measure the response across single ascending doses.
MAD studies
MAD studies define steady-state exposure and safety over multiple doses.
Dosing
Together, they build the evidence base for dosing, regulatory approvals, and investor milestones.
Our Capabilities in Porto
FIH Safety Oversight with 24/7 hospital integration
Integrated SAD/MAD Protocols (includes Food Effect, Drug–Drug Interactions, QTc evaluations)
Adaptive Design Expertise for efficient escalation and decision-making
Rapid PK/PD Turnaround ~48/72h – real-time analysis to accelerate cohort reviews
Proof-of-Concept Transition into patients via Astrum’s 11-hospital research network
24/7 hospital
Why Astrum
- Hospital-based environment for unmatched safety in early trials
- 60 dedicated beds supporting parallel cohorts and flexibility
- Faster approvals in Portugal – FIH studies cleared in 31 days approvals for mononational studies (vs. 12–16 weeks in Belgium)
- Global recognition – EMA, FDA, ANVISA Inspected
- Trusted partner for biotech and pharmaceutical sponsors – data packages designed to de-risk development and support regulatory and investment milestones