The purpose of this study is to determine a safe and effective dose range for intravenous administration (infusion) of PDC31 by determining the maximum tolerated dose of PDC31 in patients with primary dysmenorrhea.
This is an open-label, multi-centre, dose-escalating first-in-human Phase I study of PDC31 in patients with primary dysmenorrhea aimed at determining the maximum tolerated dose (MTD) of PDC31 in this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.
Innsbruck Medical University
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
University Hospital Hamburg-Eppendorf
Hamburg, Germany
University of Mainz
Mainz, Germany
Occurrence of Dose-Limiting Toxicity
Time frame: Observed following PDC31 administration to 30 day follow-up
Pharmacokinetic profiling of PDC31 and pharmacodynamic effects of PDC31 as observed on uterine contractility
Time frame: Observed immediately following PDC31 administration
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