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First-in-Human (FIH) Clinical Study of NM8074 in Healthy Adult Volunteers

NovelMed Therapeutics · 2020
ClinicalTrials.gov · Datasets · License: Public Domain · 2020
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This is a Phase 1 randomized, double-blind, placebo-controlled, single administration, sequential cohort with sentinel dosing, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of NM8074 in healthy subjects. This study will include 5 cohorts, with each cohort consisting of a total of 8 healthy subjects, including both males and females, randomized in a 3:1 ratio of NM8074 to placebo (6 subjects assigned to NM8074 and 2 subjects assigned to placebo).
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