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A Phase 1, Randomized, Single-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic Effects and Immunogenicity of RN0361 in Adult Subjects With Elevated Triglycerides
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of single and multiple doses of RN0361 in Adult subjects.
A Phase 1, Randomized, Single-blinded, Placebo-controlled, Single-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of RN0191 in Adult Subjects With Elevated Low-Density Lipoprotein-Cholesterol
Objectives: The primary and secondary objectives of the study are presented below. Exploratory objectives are presented in the body of the protocol.
Primary:
• To determine the safety and tolerability of RN0191 administered as escalating single subcutaneously (SC) doses in adult subjects with elevated low-density lipoprotein-cholesterol
Secondary:
* To evaluate the single-dose pharmacokinetics (PK) of RN0191 in adult subjects with elevated low-density lipoprotein-cholesterol
* To evaluate the pharmacodynamic (PD) effect of RN0191 on serum levels of low-density lipoprotein-cholesterol (LDL-C)
* To evaluate the PD effect of RN0191 on plasma levels of proprotein convertase subtilisin/kexin type 9 (PCSK9)
100 项与 Ikaria Bioscience Pty Ltd 相关的临床结果
0 项与 Ikaria Bioscience Pty Ltd 相关的专利(医药)
100 项与 Ikaria Bioscience Pty Ltd 相关的药物交易
100 项与 Ikaria Bioscience Pty Ltd 相关的转化医学