A Phase 1, Double blind, Randomized Study to assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Subcutaneous APL-2 Dose in Healthy Volunteers

Clinical Network Services (CNS) Pty Ltd0 个研究点目标入组 20 人开始时间: 2014年12月11日最近更新: 2021年1月5日

适应症

试验速览

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•Healthy adult male or female subject; body mass index (BMI) greater than or equal to 18.5 and less than or equal to 32.0 (kg/m2); weight greater than or equal to 60.0 kg and less than or equal to 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.
•* Subject has a history of chronic infections (eg COPD) or any active infection
•* 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
•* Subjects who have participated in the Single Ascending Dose study with APL-2

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