[Translation] A randomized, double-blind, placebo-controlled, multicenter Phase II clinical trial to evaluate the efficacy and safety of PE-001 tablets in the treatment of adult male premature ejaculation (PE) subjects

以安慰剂为对照，探索不同剂量 PE-001 片治疗男性早泄受试者的有效性；

[Translation]

Using placebo as control, explore the effectiveness of different doses of PE-001 tablets in treating male subjects with premature ejaculation;

Start Date28 Dec 2023

Sponsor / Collaborator

Liaoning Green Biological Pharmaceutical Group Co., Ltd.

[+2]

100 Clinical Results associated with PE-001

100 Translational Medicine associated with PE-001

100 Patents (Medical) associated with PE-001

Literatures (Medical) associated with PE-001

01 Jan 2022·Journal of Gastroenterology and HepatologyQ3 · MEDICINE

Establishing the blood reference interval of pancreatic elastase‐1: A prospective study

Q3 · MEDICINE

Article

Author: Lin, Jaw‐Town ; Dong, Wei‐Ting ; Wang, Jiunn‐Min ; Yang, Sheng‐Shun ; Lee, Teng‐Yu ; Wang, Ya‐Yu ; Lai, Chia‐Yeh ; Chi, Su‐Fen

AbstractBackground and AimPancreatic elastase‐1 (PE‐1) has been investigated in pancreatic disorders. However, the reference interval (RI) of PE‐1 in blood remains unconfirmed. We aimed to establish the blood RI of PE‐1 in an adult population.MethodsIn this prospective cross‐sectional study, we enrolled 400 adults who had received the whole‐body physical check‐up program between May 1, 2019 and November 20, 2019. The serum and plasma PE‐1 levels were measured by latex turbidimetric immunoassay in different storage conditions (fresh, refrigerated, and frozen). The 95% and 99% RI of PE‐1 were calculated according to the Clinical & Laboratory Standards Institute guidelines. The correlations between PE‐1 and other parameters were analyzed using multivariable regression models. Ultimately, 38 patients with acute pancreatitis were prospectively recruited as the validation cohort.ResultsThe PE‐1 levels in fresh serum were highly correlated with those in refrigerated (R2 = 0.998) or frozen (R2 = 0.942) samples; however, plasma should not be suggested in frozen conditions (plasma vs serum: R2 = 0.185). In the RI study population (202 male & 198 female participants), the median age was 52.6 (25–75% interquartile range: 43.1–61.0). The 95% and 99% RIs of PE‐1 were 30.0–221.0 and 22.0–359.0 ng/dL, respectively. Triglycerides (β = 0.106, P = 0.033), lipase (β = 0.154, P = 0.007), and CA19–9 (β = 0.130, P = 0.008) were independent factors associated with PE‐1. In the pancreatitis validation cohort, with a cut‐off value of 359.0 ng/dL, the sensitivity and specificity were 100% and 99.8%, respectively.ConclusionThe RI of PE‐1 established in this study can be used for further applications. Serum is the suggested form for frozen sample storage.

01 Oct 2021·Science of The Total EnvironmentQ2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Confirmation of biodegradation of low-density polyethylene in dark- versus yellow- mealworms (larvae of Tenebrio obscurus versus Tenebrio molitor) via. gut microbe-independent depolymerization

Q2 · ENVIRONMENTAL SCIENCE & ECOLOGY

Article

Author: Ding, Jie ; Ren, Nan-Qi ; Zhao, Lei ; Wu, Wei-Min ; Xing, De-Feng ; Yang, Shan-Shan ; Cao, Guang-Li ; Zhang, Zhi-Rong ; Bai, Shun-Wen ; Pang, Ji-Wei ; Ding, Meng-Qi

Tenebrio obscurus (Coleoptera: Tenebrionidae) larvae are capable of biodegrading polystyrene (PS) but their capacity for polyethylene (PE) degradation and pattern of depolymerization remains unknown. This study fed the larvae of T. obscurus and Tenebrio molitor, which have PE degrading capacity, two commercial low-density PE (LDPE) foams i.e., PE-1 and PE-2, with respective number-average molecular weights (M_n) of 28.9 and 27.3 kDa and weight-average molecular weights (M_w) of 342.0 and 264.1 kDa, over a 36-day period at ambient temperature. The M_w of residual PE in frass (excrement) of T. obscurus, fed with PE-1 and PE-2, decreased by 45.4 ± 0.4% and 34.8 ± 0.3%, respectively, while the respective decrease in frass of T. molitor was 43.3 ± 0.5% and 31.7 ± 0.5%. Data analysis showed that low molecular weight PE (<5.0 kDa) was rapidly digested while longer chain portions (>10.0 kDa) were broken down or cleaved, indicating a broad depolymerization pattern. Mass balance analysis indicated nearly 40% of ingested LDPE was digested to CO₂. Antibiotic suppression of gut microbes in T. molitor and T. obscurus larvae with gentamicin obviously reduced their gut microbes on day 15 but did not stop depolymerization because the M_n, Mw and size- average molecular weight (M_z) decreased. This confirmed that LDPE biodegradation in T. obscurus was independent of gut microbes as observed during previous PS degradation in T. molitor, suggesting that the intestinal digestive system could perform LDPE depolymerization. High-throughput sequencing revealed significant shifts in the gut microbial community during bran-fed and unfed conditions in response to LDPE feeding in both Tenebrio species. The respective predominant gut genera of Spiroplasma sp. and Enterococcus sp. were observed in LDPE-fed T. molitor and T. obscurus larvae.

03 Jul 2019·Journal of Agricultural and Food ChemistryQ1 · AGRICULTURAL & FORESTRY SCIENCE

PE-1, Encoding Heme Oxygenase 1, Impacts Heading Date and Chloroplast Development in Rice (Oryza sativa L.)

Q1 · AGRICULTURAL & FORESTRY SCIENCE

Article

Author: Lin, Xue ; Dai, Zhijun ; Zhu, Xudong ; Lu, Caolin ; Zhang, Yilan ; Hu, Ping ; Li, Sanfeng ; Lin, Han ; Xu, Na ; Jiao, Ran ; Rao, Yuchun ; Hu, Juan ; Wang, Yuexing

The duration of the rice growth phase has always been an important target trait. The identification of mutations in rice that alter these processes and result in a shorter growth phase could have potential benefits for crop production. In this study, we isolated an early aging rice mutant, pe-1, with light green leaves, using γ-mutated indica rice cultivar and subsequent screening methods, which is known as the phytochrome synthesis factor Se5 that controls rice flowering. The pe-1 plant is accompanied by a decreased chlorophyll content, an enhanced photosynthesis, and a decreased pollen fertility. PE-1, a close homologue of HY1, is localized in the chloroplast. Expression pattern analysis indicated that PE-1 was mainly expressed in roots, stems, leaves, leaf sheaths, and young panicles. The knockout of PE-1 using the CRISPR/Cas9 system decreased the chlorophyll content and downregulated the expression of PE-1-related genes. Furthermore, the chloroplasts of pe-1 were filled with many large-sized starch grains, and the number of osmiophilic granules (a chloroplast lipid reservoir) was significantly decreased. Altogether, our findings suggest that PE-1 functions as a master regulator to mediate in chlorophyll biosynthesis and photosynthetic pathways.

100 Deals associated with PE-001

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Indication	Highest Phase	Country/Location	Organization	Date
Premature Ejaculation	Phase 2	CN	Liaoning Green Biological Pharmaceutical Group Co., Ltd.	28 Dec 2023
Premature Ejaculation	Phase 2	CN	China Pharmaceutical University	28 Dec 2023
Premature Ejaculation	Phase 2	CN	Yuanyan Pharmaceutical Port Life Science Research (Liaoning) Co., Ltd.	28 Dec 2023

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