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Immunon宣布Travelan®第2组临床研究开始

Immuron Announces Travelan® Clinical Study Cohort 2 commences

GlobeNewswire 等信源发布 2023-10-18 18:00

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Highlights: Second cohort of 34 healthy volunteers enrolled in the Travelan® Clinical Trial Clinical Trial to examine a dosing regimen for Travelan® more suited to the US military has commenced the second cohortThe clinical study 6 month follow up of Cohorts 1 and 2 anticipated to be completed in April 2024Travelan® is known to protect against the onset of Traveler’s diarrhea (TD), the most common illness reported by travelers MELBOURNE, Australia, Oct.

亮点:第二组34名健康志愿者参加了Travelan®临床试验临床试验,以检查更适合美国军方的Travelan®给药方案已开始第二组临床研究第1组和第2组的6个月随访预计将于2024年4月完成Ravelan®可防止旅行者腹泻(TD)的发作,10月澳大利亚墨尔本旅行者报告的最常见疾病。

18, 2023 (GLOBE NEWSWIRE) -- Immuron Limited (ASX: IMC; NASDAQ: IMRN), an Australian based and globally integrated biopharmaceutical company, is pleased to announce the second cohort of 34 participants have commenced the clinical trial to evaluate the efficacy of Travelan® to prevent infectious diarrhea caused by enterotoxigenic Escherichia coli (ETEC).

182023(GLOBE NEWSWIRE)-澳大利亚全球综合生物制药公司Immuron Limited(ASX:IMC;纳斯达克:IMRN)很高兴地宣布第二批34名参与者开始进行临床试验以评估Travelan®预防由肠毒素大肠杆菌(ETEC)引起的感染性腹泻的功效。

The clinical study is being led by Principal Investigator Dr Mohamed Al-Ibrahim at the Pharmaron CPC FDA inspected Clinical Research Facility Inpatient Unit located in Baltimore, Maryland US. The Phase 2 clinical trial is designed to evaluate the safety and protective efficacy of Travelan® compared to a placebo in a controlled human infection model (CHIM).

该临床研究由位于美国马里兰州巴尔的摩的Pharmaron CPC FDA检查的临床研究机构住院病房的首席研究员Mohamed Al Ibrahim博士领导。第二阶段临床试验旨在评估Travelan®的安全性和保护效果。与受控人类感染模型(CHIM)中的安慰剂相比。

The primary efficacy outcome is prevention and/or reduction of moderate to severe diarrhea. ClinicalTrials.gov Identifier: NCT05933525. The first cohort in-patient stage of the study was completed in August 2023. Immuron received confirmation that a second cohort of 34 study participants were admitted to the Pharmaron inpatient facility and randomized to receive either Travelan® or placebo.

主要疗效结果是预防和/或减少中度至重度腹泻。ClinicalTrials.gov标识符:NCT05933525。该研究的第一个队列住院阶段于2023年8月完成。Immuron收到确认,第二组34名研究参与者被送往Pharmaron住院医院,随机接受Travelan®或安慰剂。

The inpatient phase for the second cohort will be completed by the end of October 2023. All study participants will return as outpatients for 2 weeks, 1 month and 6 month follow-up visits. Headline results from the clinical trial a.

第二队列的住院阶段将于2023年10月底完成。所有研究参与者将作为门诊病人返回2周,1个月和6个月的随访。标题临床试验结果a。