Phase I Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, PK, PD of CKD-504 in Single SAD and MAD in Healthy Korean and Caucasian Adult Male and Female Subjects

To assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending oral doses of CKD-504 compared to placebo in healthy Korean and Caucasian adult subjects

Start Date23 May 2018

Sponsor / Collaborator

Chong Kun Dang Pharmaceutical Corp.

100 Clinical Results associated with CKD-504

100 Translational Medicine associated with CKD-504

100 Patents (Medical) associated with CKD-504

Literatures (Medical) associated with CKD-504

17 Jun 2024·Journal of Clinical Investigation

Dietary dicarboxylic acids provide a nonstorable alternative fat source that protects mice against obesity

Article

Author: Pfister, Katherine E ; Mullett, Steven J ; Zhang, Yuxun ; Silva Barbosa, Anne ; Shah, Samah ; Bharathi, Sivakama S ; Goetzman, Eric S ; Rao, Krithika S ; Dobrowolski, Steven F ; Sims-Lucas, Sunder ; Solo, Keaton J ; Schilling, Birgit ; Richert, Adam C ; Gelhaus, Stacy L ; Bons, Joanna ; Rose, Jacob ; Zhang, Bob B ; Schmidt, Alexandra V ; Shiva, Sruti S

Dicarboxylic fatty acids are generated in the liver and kidney in a minor pathway called fatty acid ω-oxidation. The effects of consuming dicarboxylic fatty acids as an alternative source of dietary fat have not been explored. Here, we fed dodecanedioic acid, a 12-carbon dicarboxylic (DC12), to mice at 20% of daily caloric intake for nine weeks. DC12 increased metabolic rate, reduced body fat, reduced liver fat, and improved glucose tolerance. We observed DC12-specific breakdown products in liver, kidney, muscle, heart, and brain, indicating that oral DC12 escaped first-pass liver metabolism and was utilized by many tissues. In tissues expressing the "a" isoform of acyl-CoA oxidase-1 (ACOX1), a key peroxisomal fatty acid oxidation enzyme, DC12 was chain shortened to the TCA cycle intermediate succinyl-CoA. In tissues with low peroxisomal fatty acid oxidation capacity, DC12 was oxidized by mitochondria. In vitro, DC12 was catabolized even by adipose tissue and was not stored intracellularly. We conclude that DC12 and other dicarboxylic acids may be useful for combatting obesity and for treating metabolic disorders.

01 Sep 2023·Preparative Biochemistry & Biotechnology

Efficient crystallization process of dodecanedioic acid by a pneumatically agitated crystallizer

Article

Author: Duan, Jiulong ; Huang, Jin ; Li, Yanjun ; Hong, Rui ; Chen, Li

Dodecanedioic acid (DC₁₂) is mainly prepared via microbial synthesis in industrial production, however, the refined products have many drawbacks, such as low purity, poor crystal size distribution (CSD), and heavily agglomerated character, to name a few. Therefore, the refining process is a crucial step in DC₁₂ preparation by microbial production. In this study, a novel pneumatically agitated crystallizer for DC₁₂ refinery by gassing crystallization was developed. A batch cooling crystallization process was developed, providing the final crystal in 82.0% yield and purity increment to 99.20% at the end of crystallization process. Optimized conditions were determined as the initial supersaturation ratio of 300:3000 (g/mL) and gassing air flow rate of 4 L/min with solution preparation temperature of 85 °C. The crystal products with significantly better morphology characteristics than the starting crude feedstocks, including crystal uniformity and color brightness, were harvested. These obtained results indicated that the pneumatically agitated crystallizer-based crystallization process without any mechanical agitation was a robust and economically feasible technique. To our knowledge, this is also the first DC₁₂ crystallization process with sole gassing agitation for unseeded batch cooling crystallization.

31 Mar 2023·BMB Reports

A novel HDAC6 inhibitor, CKD-504, is effective in treating preclinical models of huntington’s disease

Author: Kim, Semi ; Seol, Wongi ; Choi, Jiwoo ; Sim, Hye-Ri ; Kim, Jiyeon ; Song, Jihwan ; Chung, Seung Soo ; Kim, Hyun Sook ; Ryu, Keun Ho ; Jun, Jae Hyun ; Li, Endan ; Ha, Nina ; Kyung, Jangbeen ; Lee, Sungsu

Huntington's disease (HD) is a neurodegenerative disorder, of which pathogenesis is caused by a polyglutamine expansion in the amino-terminus of huntingtin gene that resulted in the aggregation of mutant HTT proteins. HD is characterized by progressive motor dysfunction, cognitive impairment and neuropsychiatric disturbances. Histone deacetylase 6 (HDAC6), a microtubule-associated deacetylase, has been shown to induce transport- and release-defect phenotypes in HD models, whilst treatment with HDAC6 inhibitors ameliorates the phenotypic effects of HD by increasing the levels of α-tubulin acetylation, as well as decreasing the accumulation of mutant huntingtin (mHTT) aggregates, suggesting HDAC6 inhibitor as a HD therapeutics. In this study, we employed in vitro neural stem cell (NSC) model and in vivo YAC128 transgenic (TG) mouse model of HD to test the effect of a novel HDAC6 selective inhibitor, CKD-504, developed by Chong Kun Dang (CKD Pharmaceutical Corp., Korea). We found that treatment of CKD-504 increased tubulin acetylation, microtubule stabilization, axonal transport, and the decrease of mutant huntingtin protein in vitro. From in vivo study, we observed CKD-504 improved the pathology of Huntington's disease: alleviated behavioral deficits, increased axonal transport and number of neurons, restored synaptic function in corticostriatal (CS) circuit, reduced mHTT accumulation, inflammation and tau hyperphosphorylation in YAC128 TG mouse model. These novel results highlight CKD-504 as a potential therapeutic strategy in HD. [BMB Reports 2023; 56(3): 178-183].

100 Deals associated with CKD-504

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Indication	Highest Phase	Country/Location	Organization	Date
Huntington Disease	Phase 1	KR	Chong Kun Dang Pharmaceutical Corp.	23 May 2018
Mandibuloacral Dysplasia With Type a Lipodystrophy	Phase 1	KR	Chong Kun Dang Pharmaceutical Corp.	23 May 2018
Seasonal Affective Disorder	Phase 1	KR	Chong Kun Dang Pharmaceutical Corp.	23 May 2018

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