Healthy Clinical Trial
Official title:
A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Doses of ZP7570 in Healthy Subjects.
This is a randomised, double-blind, placebo-controlled, multiple ascending dose trial in healthy subjects, randomised to ZP7570 or placebo within each cohort
Thirty subjects are planned to be studied in three cohorts in this multiple ascending dose trial. Ten subjects will be allocated to three dose levels. Intermediate dose levels may be applied. A sentinel dosing approach (sequential dosing) will be applied. The entire observation period comprises 51 days starting with a 96 hours in-house stay after the first dose injection (V2), where discharge is planned for Day 5, followed by one outpatient visits. For the second (V4) and the third (V5) injection dose a 36 hours in-house stay is planned. After the fourth (V6) dose injection there is also a 96 hour in-house stay where discharge is planned for Day 26, followed by five outpatient visits (V7-11) and an End of Trial Visit on Day 51 (V12). A blinded evaluation of each cohort will be performed by a Trial Safety Group to determine whether the trial will progress to the next planned dose level based on the stopping rules specified in protocol ;
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