A randomized, double-blind, placebo-controlled investigation of the safety, tolerability and pharmacokinetics of 1% SPL7013 nasal spray in healthy volunteers when administered four times a day for 14 days

Starpharma Pty Ltd0 个研究点目标入组 40 人开始时间: 2020年12月22日最近更新: 2022年6月27日

研究概览

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•1.Male and female, aged 18 to 65 years, inclusive.
•2.In good general health, with no significant medical history, no clinically significant abnormalities on physical examination at screening and/or before administration of the initial application of the investigational device.
•3.Body Mass Index (BMI) between 18.0 and 32.0 kg/sqm, inclusive.
•4.Clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or delegate.
•5.Non-smoker and must not have used any nicotine containing products within 2 months prior to screening.
•6.Written informed consent signed prior to entry into the investigation.

•1.Prior or ongoing medical condition, medical history, physical findings or laboratory abnormality that, in the Investigator’s (or delegate’s) opinion, could adversely affect the safety of the participant.
•2.Abnormal and/or clinically significant findings upon examination of the nasal cavity .
•3.Has received an investigational drug, other investigational device, or approved therapy for investigational use within 30 days or 5 half-lives of the drug, whichever is longer, prior to screening.
•4.Pregnant or breastfeeding.
•5.Fever (body temperature >=38°C) or symptomatic viral or bacterial infection within 2 weeks prior to screening.
•6. Known allergy to SPL7013 or any of the spray components
•7.Participant has used any kind of nasal product within 7 days prior to the start of the investigation, and/or the use of nasal products during the investigation is anticipated.

发起方