更新于：2024-12-20
SCOHIA PHARMA, Inc.
更新于：2024-12-20
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Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial to investigate tolerability, safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SCO-094 subcutaneously administered in patients with type 2 diabetes
Randomized, placebo-controlled, double-blind, single-centre, Phase 1 trial to investigate tolerability, safety, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of SCO-094 subcutaneously administered in patients with type 2 diabetes
A Randomized, Multi-center, Double-blind, Placebo-controlled, Parallel-group Comparison, Phase 2a Study to Evaluate the Safety, Tolerability and Efficacy of SCO-792 in Subjects with Type 2 Diabetes and Albuminuria.
100 项与 SCOHIA PHARMA, Inc. 相关的临床结果
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2024-06-01Clinical pharmacology and therapeutics
Oral SSTR5 Antagonist SCO ‐240 for Growth Hormone Stimulation: A Phase I Single‐Dose Study in Healthy Individuals
Article
作者: Kagawa, Tomoya ; Kobayashi, Akihiro ; Sugama, Jun ; Nishizaki, Harunobu ; Moritoh, Yusuke ; Watanabe, Masanori
Somatostatin inhibits endocrine and exocrine secretion in various tissues by acting on five somatostatin receptor subtypes (SSTR1–5). The clinical effects of SSTR5 antagonism remain unknown. Herein, we evaluated the effects of SCO‐240, an oral SSTR5 antagonist, in healthy individuals. This randomized, single‐center, double‐blind, placebo‐controlled, phase I study included healthy Japanese and White individuals. The effects of ascending single oral doses of SCO‐240 were evaluated in healthy individuals. The main outcome measures were safety, tolerability, pharmacokinetics, and pharmacodynamics (gallbladder contractions and levels of serum insulin and plasma glucagon‐like peptide‐1 (GLP‐1)). The levels of pituitary hormones were evaluated in our exploratory analysis. The results indicated that SCO‐240 was safe and well‐tolerated at all tested doses. Oral SCO‐240 was readily absorbed, with its systemic exposure increasing in a dose‐dependent manner. The median time to maximum concentration and mean terminal half‐life of SCO‐240 were 3–4 and 10.2–12.6 hours, respectively, in the ascending dose section. No clinically meaningful changes in SCO‐240 pharmacokinetic profiles were observed between fed and fasted or between Japanese and White individuals. No increase in gallbladder contractions or levels of insulin and GLP‐1 were detected. SCO‐240 induced robust growth hormone (GH) secretion without altering the levels of other pituitary hormones. In conclusion, the study is the first to demonstrate that SSTR5 antagonism stimulates GH secretion in humans. SCO‐240 was safe and well‐tolerated and exhibited once‐daily oral dosing potential. The robust effects of SCO‐240 on GH secretion suggest that it may be a treatment option for GH‐related disorders.
2023-01-01Kidney international reports
An Exploratory Randomized Trial of SCO-792, an Enteropeptidase Inhibitor, in Patients With Type 2 Diabetes and Albuminuria
Article
作者: Kagawa, Tomoya ; Sugama, Jun ; Nishizaki, Harunobu ; Moritoh, Yusuke ; Watanabe, Masanori
Introduction:
Elevated plasma amino acid levels overload kidney function by increasing glomerular filtration rate (GFR). Inhibiting gut amino acid intake may have therapeutic benefits for patients with kidney dysfunction. For a prospective phase 2a trial, we carried out an exploratory evaluation of the safety and efficacy of SCO-792, an enteropeptidase inhibitor that blocks gut amino acid intake, in patients with type 2 diabetes mellitus (T2DM) and albuminuria.
Methods:
Seventy-two patients with T2DM, a urine albumin-to-creatinine ratio (UACR) of 200-5000 mg/g, and an estimated GFR >30 ml/min per 1.73 m2 were included. Patients were randomly assigned (1:2:2) to the following groups and received treatment for 12 weeks: placebo (n = 15), SCO-792 500 mg once daily (SCO-792 QD; n = 29), or SCO-792 500 mg 3 times daily (SCO-792 3 times a day (TID); n = 28) by following a double-blind approach. We evaluated UACR changes from the baseline along with safety as the primary end points and other parameters as secondary or exploratory end points.
Results:
SCO-792 was safe and well tolerated up to 1500 mg/day for 12 weeks. UACR changes from baseline were -14% (P = 0.4407), -27% (P = 0.0271), and -28% (P = 0.0211) in placebo, SCO-792 QD, and SCO-792 TID, respectively, whereas UACR changes in SCO-792 groups were not statistically significant compared with placebo. The hemoglobin A1c (HbA1c) levels from baseline, an exploratory end point, decreased in the SCO-792 TID group.
Conclusion:
SCO-792 was safe and well tolerated for 12 weeks and may be associated with decreased UACR in patients with T2DM and albuminuria. Further clinical studies are essential to confirm our findings.
2022-10-01Journal of chromatography. A
Liquid chromatography-mass spectrometry measurements of blood diphosphoinositol pentakisphosphate levels
Article
作者: Kobayashi, Akihiro ; Abe, Shin-Ichi ; Moritoh, Yusuke ; Watanabe, Masanori
Diphosphoinositol pentakisphosphate (InsP7) is an inositol pyrophosphate generated by inositol hexakisphosphate kinases (IP6Ks) that regulate diverse biological functions in cells. To date, we have a limited understanding of the InsP7 biology owing to limited data on InsP7 levels in blood or other tissues. Given the significant role of InsP7 in maintaining biological homeostasis, further advancement in InsP7 measurement is essential. In this study, we report a highly sensitive liquid chromatography with tandem mass spectrometry method for determining InsP7 levels in whole blood, which is an easily accessible tissue and for which knowledge on InsP7 levels is limited. We applied a perchloric acid-based method to increase the extraction efficiency of InsP7 from the cells. Subsequently, we combined a YMC-Triart C18 metal-free column, ion-pair reagents, EDTA, methylenediphosphonic acid, and N,N,N',N'-Ethylenediaminetetrakis(methylenephosphonic acid) to minimize InsP7 adsorption to the detection system. We prepared blood quality control samples that were highly exposed to IP6K inhibitor, showing minimum InsP7 levels, to decrease the lower quantification limit of InsP7. Furthermore, we applied rat plasma, which was found to show no InsP7 levels, as a surrogate matrix. This setting resulted in the highly sensitive detection of InsP7 levels in blood obtained from rats, with a quantification sensitivity of 1 ng of InsP7 per mL of blood. The current method demonstrated acceptable accuracy (100 ± 15%) and precision (coefficient of variation ≤ 15%) in rat blood. Using this method, we revealed endogenous basal levels of InsP7 (37.4 ng/mL) in blood obtained from normal rats, and decreased levels of InsP7 (4.1-21.7 ng/mL) in blood obtained from IP6K inhibitor-administered rats. In summary, we established a highly sensitive method for measuring InsP7 and revealed its levels in rat blood. The current findings may help in understanding InsP7 biology.
2024-10-01
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2024-07-12
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2024-06-17
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