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最高研发阶段临床2期 |
首次获批国家/地区- |
首次获批日期- |
DP13 – A Phase II Study in Patients with Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of the Aldosterone Synthase Inhibitor, DP13, over an 8-week Treatment Period - -
DP13 - A Phase II Study in Patients With Primary Aldosteronism to Evaluate the Efficacy, Safety and Tolerability of DP13, Over an 8-week Treatment Period
The purpose of the present phase II study is to determine whether DP13 displays the clinical safety and efficacy profile to support further development in patients with primary aldosteronism.
A Phase 1, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Oral Dose, Safety, Tolerability, Pharmacodynamic, and Pharmacokinetic Study of DP13 in Healthy Male Subjects
Primary Objectives:
To determine the safety and tolerability of single and multiple oral doses of DP13 in healthy male subjects
To assess the pharmacodynamics of single and multiple ascending oral doses as well as dosing regimen of DP13 on suppression of serum aldosterone in healthy male subjects
Secondary Objectives:
To determine the single and multiple oral dose pharmacokinetics of DP13 in healthy male subjects
To determine the dose-dependent pharmacodynamic selectivity of DP13 in healthy male subjects
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