A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects With Early Parkinson's Disease

A Phase IIa, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of MT101-5 in Subjects with Early Parkinson's Disease. Primary objective of the study is to evaluate the safety and tolerability of MT101-5 400 mg and 600 mg oral tablet total daily dose compared to Placebo in subjects with Parkinson's Disease.

开始日期2024-07-01

申办/合作机构

Mthera Pharma初创企业

NCT05844787 / Completed临床1期

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study Including a Food Interaction Study, Followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability and Pharmacokinetics Profile of MT101-5 in Healthy Volunteers

The primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers. The safety and overall tolerability of MT101-5 will be evaluated based on:
Incidence of Dose Limiting Toxicities (DLTs)
Incidence of Treatment-Emergent Adverse Events (TEAEs).
Incidence of withdrawals due to Adverse Events (AEs).
Change/shifts in laboratory values. Change in vital signs.
Change in Electrocardiogram (ECG) parameters.
Changes in physical examination findings

开始日期2022-07-11

申办/合作机构

Mthera Pharma初创企业

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100 项与 MT101-5 相关的临床结果

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100 项与 MT101-5 相关的转化医学

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100 项与 MT101-5 相关的专利（医药）

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项与 MT101-5 相关的文献（医药）

2022-10-01·Biomedicine & Pharmacotherapy

Inhibition of α-synuclein aggregation by MT101-5 is neuroprotective in mouse models of Parkinson’s disease

Article

作者: Son, Miwon ; Kim, Se Woong ; Park, Dong Seok ; Lee, Choong Hwan ; Kim, Sinyeon ; Choi, Jin Gyu ; Park, Sang Cheol ; Kang, Yu-Ra

Parkinson's disease (PD) is the second most common neurodegenerative disease, after Alzheimer's disease, and becomes increasingly prevalent with age. α-Synuclein (α-syn) forms the major filamentous component of Lewy bodies, which are pathological hallmarks of α-synucleinopathies such as PD. We evaluated the neuroprotective effects of MT101-5, a standardized herbal formula that consists of an ethanolic extract of Genkwae Flos, Clematidis Radix, and Gastrodiae Rhizoma, against α-synuclein-induced cytotoxicity in vivo. MT101-5 protected against behavioral deficits and loss of dopaminergic neurons in human α-syn-overexpressing transgenic mice after treatment with 30 mg/kg/day for 5 months. We investigated transcriptomic changes within MT101-5 mechanisms of action (MOA) suppressing α-syn aggregation in an α-synuclein preformed fibril (α-syn PFF) mouse model of sporadic PD. We found that inhibition of α-syn fibril formation was associated with changes in transcripts in mitochondrial biogenesis, electron transport, chaperones, and proteasomes following treatment with MT101-5. These results suggest that the mixed herbal formula MT101-5 may be used as a pharmaceutical agent for preventing or improving PD.

100 项与 MT101-5 相关的药物交易

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