Module 9 2024

03/09/2024

An Example of a First-In-Human Study

• Single-ascending dose (SAD) study in Healthy Volunteers • IMP: a monoclonal antibody acting as an immunosuppressive

• Clearance is slow: activity of IMP is prolonged • Target is established: potential risks are known • Potential risks: prolonged immunosuppression, infusion reactions • Risk Mitigation: stagger dosing, allow for follow-up between each cohort • Start to end duration: potentially >6 months

The Organisation for Professionals in Regulatory Affairs

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An Example of a First-In-Human Study (Cont.)

Randomisation 2:1 (active:placebo)

Key

Recruitment: 2-3 weeks

Dosing: 1 week

Safety period: 4 weeks

Safety review Safety follow up: 2 months

The Organisation for Professionals in Regulatory Affairs

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