First in Man Clinical Study of a New Drug-RGN1016

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Project title/計畫英文名

Project Number/計畫編號

MOST104-2325-B002-042

Translated Name/計畫中文名

新藥-RGN1016首次於人體進行Phase I 臨床試驗

Project Principal Investigator/計畫主持人

MING-JANG CHIU

Co-Investigator(s)/共同執行人

WEN-MEI FU
TA-FU CHEN

Funding Organization

Ministry of Science and Technology

Department/Unit

Neurology

Start date/計畫起

01-11-2015

Expected Completion/計畫迄

31-10-2016

摘要：這是一個新藥RGN1016之第一期臨床試驗計畫。依據臨床則試驗結果，RGN1016可以穩定 NO-soluble guanylate cyclase而增加cGMP達數百倍之多，再藉由cGMP-PKG-ERK路徑與BDNF的表現，以達到增強杏仁核與海馬迴的長期增益效應。此外，動物行為試驗也發現RGN1016可以增強年輕老鼠及老年癡呆鼠的學習和記憶力。因此，預期RGN1016在人體頗具有治療輕微知能障礙與阿茲海默症的潜力。計畫主要目的為以健康男性受試者為對象，評估口服RGN1016的安全性及耐受性。計畫的次要目的為藉由血中及尿中藥物濃度之偵測，評估RGN1016中有效成分之吸收速率快慢、吸收總量多寡及排除速率；此外，因為不具侵入性，也將使用CDR系統同時評估RGN1016對健康受試者學習及記憶力的影響。第一年的計畫內容為第一階段單劑量、劑量遞增、第一期臨床試驗，預計招募40位受試者，共五個劑量群組(50、100、200、400及800毫克），每個劑量群組納入8位受試者，以3:1的比例隨機分配使用單一劑量的RGN1016或安慰劑(6位接受RGN1016，2位接受安慰劑)。第一個劑量群組是50 毫克。
Abstract: This is a project for the phase I clinical trial of a new drug RGN1016. Based on the results of pre-clinical studies, RGN1016 stabilizes the NO-soluble guanylate cyclase and thus produces cGMP up to several hundred folds. RGN1016 then enhances the long-term potentiation in hippocampus and amygdala through cGMP-PKG-ERK pathway and the increase of brain-derived neurotrophic factor (BDNF) expression. In addition, the behavior tests also show that RGN1016 markedly enhances the learning and memory in both young rodents and aged APP/PS1 mice (an Alzheimer’s disease model). As a result, RGN1016 may be helpful for mild cognitive impairment (MCI) or Alzheimer’s disease patients.The primary objective is to assess the safety and tolerability of RGN1016. The secondary objectives are to assess the pharmacokinetic profiles of RGN1016 after oral administration of RGN1016. We will also evaluate the effect of RGN1016 on subject’s learning and memory by using CDR system-a not invasive procedure.The study includes two stages, Stage I: single dose, dose escalating study; Stage II: multiple doses, dose escalating study. Stage II will not be initiated until an interim safety report of Stage I has been approved by FDA.Stage I is planned to complete in the first year. Stage I is planned to recruit 40 subjects and 8 subjects in each cohort for 5 cohorts: 50 mg qd, 100 mg qd, 200 mg qd, 400 mg qd and 800 mg qd. Subjects in each cohort will be randomized in 3:1 ratio, i.e., 6 subjects receive assigned dosage of RGN1016 and 2 subjects receive placebo. The first cohort will be 50 mg.

Keyword(s)

RGN1016
學習障礙
阿茲海默症
第一期臨床試驗
藥物動力學
安全性
耐受性
RGN1016
cognitive impairment
Alzheimer5 s disease
Phase I clinical trial
pharmacokinetics
safety
tolerability

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First in Man Clinical Study of a New Drug-RGN1016

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