A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered BW-20829 in subjects with elevated lipoprotein(a)

Argo Biopharma Australia Pty Ltd0 个研究点目标入组 40 人开始时间: 2023年11月21日最近更新: 2024年1月29日

适应症

试验速览

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•1.Must have given written informed consent and be able to comply with all study requirements.
•2.Males or females aged 18 to 65 years old, inclusive, at the time of informed consent.
•3.Lp(a) >=50 mg/dL (125 nmol/L).
•4.Body mass index >=18 and <=35 kg/m2 with body weight >50 kg.
•5. Female subjects must be non-pregnant and non-lactating, and either surgically sterile or postmenopausal. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, can participate if they are using highly effective methods of contraception from 28 days prior to dosing until 12 weeks following administration of the study drug.
•6.Male subjects with female partners of child-bearing potential must agree to use acceptable methods of contraception from 28 days prior to dosing until 12 weeks following administration of the study drug.

•1.Any uncontrolled or serious disease, or any medical or surgical condition including evidence of unstable cardiovascular disease, and other serious medical or psychiatric illness/condition.
•2.Hospitalization for any reason within 60 days of screening.
•3.Any history of clinically overt cardiovascular disease, defined as acute coronary syndromes, myocardial infarction, stable angina, coronary or other revascularization, ischemic stroke or transient ischemic attack and atherosclerotic peripheral arterial disease.
•4.Any clinically significant acute condition such as fever (>38°c) or acute respiratory illness within 7 days of study drug administration.
•5.Clinical laboratory findings outside of range are deemed clinically significant by the investigator at screening or Day -1.
•6.History or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms (in the judgement of investigator).

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