Healthy Subjects Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Escalating Doses of Intravenous Zidebactam in Healthy Adult Human Subjects
Study to evaluate the safety and tolerability of multiple escalating doses of intravenous (IV) Zidebactam in healthy adult human subjects.
A double-blind, placebo-controlled study where healthy adult subjects will be randomly
assigned to receive either of the investigational products (Zidebactam or placebo) in 2
multiple ascending dose (MAD) cohorts.
Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of
intravenous (IV) zidebactam in healthy adult human subjects.
Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of
IV zidebactam in healthy adult human subjects.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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