Module 9 2021

19/03/2021

An Example of a First-In-Human Study

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

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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)

Recruitment: 2-3 weeks Safety period: 4 weeks Dosing: 1 week Safety review

Safety follow up: 2 months

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The Organisation for Professionals in Regulatory Affairs

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