What type of study is this?

This is a RCT study (also classified as: Phase 2).

Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of Bexicaserin in Healthy Participants: A First‐in‐Human Randomized, Double‐Blind, Placebo‐Controlled Single Ascending Dose Escalation Phase 1 Study

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Randomized trial assessed safety and pharmacokinetics of bexicaserin in healthy adults, indicating favorable tolerability.

Bexicaserin demonstrated good safety and tolerability in healthy adults, with mild to moderate treatment-related adverse events.
Plasma levels of bexicaserin increased significantly with dose escalation, showing a greater than 55-fold increase for maximal dosing.
Observational analysis across healthy adults characterized the pharmacokinetics and pharmacodynamics, confirming the drug's promising profile.
Overall, these findings may support bexicaserin's further development in treating seizures related to developmental and epileptic encephalopathies.

Chan et al. (2025) studied this question.

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