A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-00112 in Adult Subjects

ARGO BIOPHARMA AUSTRALIA PTY LTD0 个研究点目标入组 32 人开始时间: 2022年11月8日最近更新: 2024年6月3日

适应症

试验速览

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•1.All subjects are required to have elevated fasting Low-density lipoprotein cholesterol > = 100 mg/dL [2.69 mmol/L] and 100 mg/dL [1.13 mmol/L] < = Triglycerides (fasting) < 500 mg/dL [5.65 mmol/L] and have not been treated with lipid-lowering medicines in the past 3 month.
•2.On a usual diet for at least 4 weeks prior to screening with no plans to significantly alter diet or weight over course of study.

•1. Any uncontrolled or serious disease or clinically significant abnormality in laboratory parameters which in the judgment of the Investigator might compromise the safety of the subject or integrity of the study, interfere with the subject participation in the trial or compromise the trial objectives.
•2.Any liver function panel analyte value > 1.5 x upper limits of normal reference range which includes Aspartate transaminase, Alanine transaminase, Total Bilirubin (for subjects with Gilbert’s Syndrome, total bilirubin < = 3.0 × upper limits of normal is allowed if direct bilirubin < = 50%), Alkaline Phosphatase, and gamma-glutamyl transferase at Screening.
•3.International normalized ratio above 1.2 x upper limits of normal reference range reference range (as per the local laboratory reference range) at screening.
•4.Calculated creatinine clearance < = 60 mL/min (Cockcroft-Gault equation).
•5.History or presence of cardiovascular disease.
•6.History or presence of Type 1 or type 2 diabetes mellitus at screening.

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