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In vitro drug screens are performed on either cell-free protein aggregates, animal-derived cell lines, or patient-derived motor neurons [7, 197]

[17] Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition

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Phase 1a: First-in-Human Single Ascending Dose Study (NCT02951806) Study Title: "Safety, Tolerability, and Pharmacokinetics of Single Doses of Cagrilintide in Healthy Subjects" Status: Completed Phase: Phase 1a Enrollment: 48 healthy volunteers Study Period: 2016-2017 Location: Single center (Denmark) Design: Randomized, double-blind, placebo-controlled, single ascending dose Dose Range: 0.03-10 mg SC Primary Endpoints: Safety, tolerability, PK parameters Population: Healthy male subjects, BMI 20-28 Key Results: Pharmacokinetics: Terminal half-life 5-7 days across dose range