[Edaily Reporter Shin Ha-yeon ] EuBiologics Co., Ltd.(206650)announced on the 18th that it has submitted an application to the South Korean Ministry of Food and Drug Safety (MFDS) for approval of a Phase 1 clinical trial plan (IND) for “PADIVAX,” a vaccine for Alzheimer’s disease.
This clinical trial will be conducted as a single-center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of PADIVAX in patients with mild cognitive impairment and mild Alzheimer’s disease caused by Alzheimer’s disease.
The target sample size is 24 participants, who will be enrolled in low-, medium-, and high-dose groups, respectively, and will receive a total of five doses of the investigational drug at four-week intervals. Safety will be evaluated for up to 52 weeks following the final dose. The clinical trial period is 60 months from the date of approval by the Institutional Review Board (IRB).
The company stated that it plans to immediately disclose relevant details upon approval of the clinical trial protocol.
This clinical trial will be conducted as a single-center, double-blind, randomized, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of PADIVAX in patients with mild cognitive impairment and mild Alzheimer’s disease caused by Alzheimer’s disease.
The target sample size is 24 participants, who will be enrolled in low-, medium-, and high-dose groups, respectively, and will receive a total of five doses of the investigational drug at four-week intervals. Safety will be evaluated for up to 52 weeks following the final dose. The clinical trial period is 60 months from the date of approval by the Institutional Review Board (IRB).
The company stated that it plans to immediately disclose relevant details upon approval of the clinical trial protocol.
