A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Subcutaneous APL-2 in Healthy Adult Subjects

Clinical Network Services (CNS) Pty Ltd0 个研究点目标入组 31 人开始时间: 2014年7月8日最近更新: 2021年1月5日

试验速览

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•Healthy adult male or female subject; body mass index (BMI) between 18.5 and 32.0 kg/m2; weight between 60.0 kg and 80.0 kg.

•* Subject is mentally or legally incapacitated or has significant emotional problems; or has a history of: clinically significant medical or psychiatric condition or disease, any illness that might confound the results of the study or pose a risk to the subject by their participation in the study, alcoholism or drug abuse, and/or hypersensitivity or idiosyncratic reaction to compounds related to APL-2 or particular antibiotics.
•*Infection within the last 4 weeks
•*Female subjects who are pregnant or lactating.
•*Use of any prescription and non-prescription medications, herbal remedies, or vitamin supplements within the last 14 days, or use of some particular drugs such as St. John’s Wort within the last 28 days, up until the end of the study (paracetamol may be permitted)
•*Blood donation or significant blood loss within the past 56 days or plasma donation within the last 7 days.
•*Participation in another clinical trial within the past 28 days
•*Significant surgery within the past 90 days
•*Presence of any scars or tattoos on the abdomen which may obscure the injection site

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