[Translation] A single-center, open-label, single-dose clinical trial evaluating the absorption, metabolism, and excretion of 3 mg/100 μCi [14C] azithromycin suspension in healthy male subjects

主要目的： 1 考察[14C]标记的阿兹夫定在健康男性受试者全血和血浆中总放射性的药代动力学特征； 2 定量分析健康男性受试者口服[14C]阿兹夫定混悬液后呼出气体与排泄物中总放射性，获得人体内物质平衡数据，确定主要排泄途径；次要目的： 1 定量分析血浆中阿兹夫定原形药物及代谢产物（如适用）浓度，获得血浆中阿兹夫定的药代动力学参数； 2 观察单剂量口服 [14C]阿兹夫定混悬剂后受试者的安全性。探索性目的： 1 测定健康男性受试者口服[14C]阿兹夫定后血浆、尿液和粪便中的放射性代谢物谱，并鉴定主要代谢产物，提供阿兹夫定在人体内的主要代谢途径数据，确定主要生物转化途径。 2 测定健康男性受试者口服[14C]阿兹夫定混悬液后，细胞内的分布情况。

[Translation]

Main objectives: 1 To investigate the pharmacokinetic characteristics of total radioactivity of [14C]-labeled azithromycin in whole blood and plasma of healthy male subjects; 2 To quantitatively analyze the total radioactivity in exhaled gas and excreta of healthy male subjects after oral administration of [14C]azithromycin suspension, obtain material balance data in the human body, and determine the main excretion pathway; Secondary objectives: 1 To quantitatively analyze the concentration of parent drug and metabolites (if applicable) in plasma of azithromycin and obtain the pharmacokinetic parameters of azithromycin in plasma; 2 To observe the safety of subjects after a single oral dose of [14C]azithromycin suspension. Exploratory objectives: 1 To determine the radioactive metabolite spectrum in plasma, urine and feces of healthy male subjects after oral administration of [14C]azithromycin, and identify the main metabolites, provide data on the main metabolic pathways of azithromycin in the human body, and determine the main biotransformation pathways. 2 To determine the intracellular distribution of [14C]azithromycin suspension in healthy male subjects after oral administration.

Start Date18 Jul 2024

Sponsor / Collaborator

Genuine Biotech Limited

[+1]

ChiCTR2400085602 / SuspendedNot ApplicableIIT

Prevalence of anal HPV infection and HPV-related precancerous lesions among MSM population in China

Start Date20 Jun 2024

Sponsor / Collaborator

Institute of Materia Medica

CTR20234094 / RecruitingPhase 1

评估在中国健康成年和老年受试者进行空腹单多剂和餐后单剂口服W1302片的安全性、耐受性、药代动力学、药效学的单中心、随机、双盲/开放Ⅰ期临床试验

[Translation] A single-center, randomized, double-blind/open phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of W1302 tablets in Chinese healthy adult and elderly subjects, with single or multiple doses on an empty stomach or a single dose after meals

主要目的：评估在中国健康成年受试者进行空腹单多剂和餐后单剂口服以及健康老年受试者空腹单剂口服W1302片的安全性和耐受性。次要目的：（1）评估在中国健康成年受试者进行空腹单多剂口服以及健康老年受试者空腹单剂口服W1302片的药代动力学（PK）特征；（2）评估进食对中国健康成年受试者单剂口服W1302片PK影响。探索性目的：（1）评价W1302片单剂口服给药后对中国健康受试者QT/QTc间期的影响；（2）初步探索在中国健康成年受试者进行空腹单多剂口服以及健康老年受试者空腹单剂口服W1302片的药效学（PD）特征；（3）初步探索W1302片在体内的代谢及排泄途径。

[Translation]

Primary objective: To evaluate the safety and tolerability of W1302 tablets in single or multiple doses and single doses after meals in healthy Chinese adult subjects and single doses in healthy elderly subjects. Secondary objectives: (1) To evaluate the pharmacokinetic (PK) characteristics of W1302 tablets in single or multiple doses in healthy Chinese adult subjects and single doses in healthy elderly subjects; (2) To evaluate the effect of single doses of W1302 tablets in healthy Chinese adult subjects on the PK. Exploratory objectives: (1) To evaluate the effect of single doses of W1302 tablets on the QT/QTc interval in healthy Chinese subjects; (2) To preliminarily explore the pharmacodynamic (PD) characteristics of W1302 tablets in single or multiple doses in healthy Chinese adult subjects and single doses in healthy elderly subjects; (3) To preliminarily explore the metabolism and excretion pathways of W1302 tablets in vivo.

Start Date06 May 2024

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

[+1]

100 Clinical Results associated with Institute of Materia Medica

0 Patents (Medical) associated with Institute of Materia Medica

462

Literatures (Medical) associated with Institute of Materia Medica

02 Aug 2024·Journal of Asian natural products research

Characterization of the metabolic contributions of cytochrome P450 isoforms to bicyclol using the relative activity factor method

Article

Author: Luo, Li-jun ; Sheng, Li ; Li, Yan ; Liu, Xiao ; Li, Yang

Bicyclol is a hepatoprotective agent widely used for treating chronic hepatitis and drug-induced liver injuries in clinics. The purpose of the study was to elucidate the contribution of CYP450 enzymes to the metabolism of bicyclol using the relative activity factor approach. After incubation with human liver microsomes and recombinant human liver CYP450 enzymes, the calculated contribution of CYP3A4 and 2C19 to the metabolism of bicyclol was 85.6-90.3% and 9.2-9.7%, respectively. The metabolism was interrupted in the presence of CYP3A4 and 2C19 selective inhibitors. These findings help to predict or avoid metabolic drug-drug interactions or toxicity in clinical applications of bicyclol.

01 May 2024·Journal of ethnopharmacology

Chemical components with antibacterial properties found in sanchen powder from traditional Tibetan medicine

Article

Author: Zhao, Yueying ; Fan, Jiayi ; Lu, Yang ; Tangthianchaichana, Jakkree ; Liu, Donghan ; Xi, Cheng ; Wu, Huichao ; Ren, Xiaoqiao

ETHNOPHARMACOLOGICAL RELEVANCE:

Sanchen powder is a traditional Tibetan medicine comprising Bambusae Concretio Silicea, Carthami Flos, and Bovis Calculus Artifactus. Bambusae Concretio Silicea is the dried mass of secreted fluid in the stalks of Gramineae plants such as Bambusa textilis McClure or Schizostachyum chinense Rendle. Carthami Flos is the dried flower of Carthamus tinctorius L. in the Compositae plant. Bovis Calculus Artifactus is made from ox bile powder, cholic acid, hyodeoxycholic acid, taurine, bilirubin, cholesterol, and trace elements. Research has evidenced the antibacterial efficacy of Sanchen powder, albeit its active constituents for this effect are yet to be established.

AIM OF THE STUDY:

To investigate effective compounds, potential targets, and molecular mechanism of Sanchen powder for its antibacterial properties by using network pharmacology combined with in vitro validation, with the aims of observing the action of effective compounds in Sanchen powder and exploring new therapeutic strategies for antibacterial.

MATERIALS AND METHODS:

In this study, UPLC-Q-TOF-MS was utilized to identify the chemical composition in Sanchen powder and its blood-borne chemical ingredients post-oral intake. A network pharmacology analysis was used to establish the chemical compound in the blood following oral administration-target-disease network. The study aimed to identify antibacterial active ingredients, which were then subjected to molecular docking and pharmacodynamic experiments to verify their efficacy.

RESULTS:

The findings demonstrate that following oral administration, the blood contains seven key components of Sanchen powder, including bilirubin, glycochenodeoxycholic acid, glycocholic acid, taurocholic acid, phenylalanine, safflomin A, and tryptophan. Additionally, the network pharmacology and molecular docking study results indicate the potential antibacterial effects of bilirubin, glycocholic acid, and glycochenodeoxycholic acid. In vitro antibacterial experiments revealed that bilirubin, glycocholic acid, and glycochenodeoxycholic acid could restrict the growth of the Staphylococcus aureus cell membrane at a certain concentration. Moreover, they exhibited antibacterial effects on Staphylococcus aureus, Pseudomonas aeruginosa, Staphylococcus epidermidis, and Escherichia coli.

CONCLUSIONS:

Bilirubin, glycocholic acid, and glycochenodeoxycholic acid could be effective therapeutic ingredients for the antibacterial effects of Sanchen powder. These results offer a foundation for further clinical application and research on the antibacterial effect of Sanchen powder, a Traditional Tibetan Medicine.

01 Jan 2024·Journal of ethnopharmacology

In silico prediction and experimental validation to reveal the protective mechanism of Puerarin against excessive extracellular matrix accumulation through inhibiting ferroptosis in diabetic nephropathy

Article

Author: Du, Guanhua ; Zhao, Xiaoyue ; Hou, Biyu ; Qiang, Guifen ; Zhang, Li ; Ma, Peng ; Zhao, Yuerong ; Yang, Xinyu ; He, Ping

ETHNOPHARMACOLOGICAL RELEVANCE:

Puerarin (PUR) isolated from the root of Pueraria lobata (Willd.) Ohwi is considered as one of the main medicines to alleviate asthenic splenonephro-yang of diabetic nephropathy (DN). Whereas, the exact mechanism of Puerarin on diabetic nephropathy is still unclear.

AIM OF STUDY:

In this study, we aimed to investigate the protective effects of PUR on type 2 diabetic nephropathy in vivo, in silico and in vitro, as well as unveil the underlying mechanism through inhibiting ferroptosis.

MATERIALS AND METHODS:

In vivo, blood glucose and lipid, renal function, kidney histology and immunohistochemistry analysis were used to vindicate the protective effects of PUR on diabetic nephropathy in type 2 DN rat model. In silico, pharmacophore matching and enrichment analysis were adopted to predict the potential mechanism of PUR on DN. In vitro, we utilized high glucose stress to induce impairment in glomerular mesangial cells (GMCs) as diabetic nephropathy cell model. Cell count kit-8 (CCK-8) was used to observe cell viability. qPCR, Western blot, immunofluorescence staining and flow cytometry were used to evaluate the effect of PUR on the generation of extracellular matrix (ECM), ferroptosis and iron homeostasis in vitro and in vivo.

RESULTS:

PUR markedly improved glucose and lipid metabolism, as well as alleviated renal dysfunction in diabetic nephropathy rats. Pharmacophore matching and enrichment analysis predicted the anti-DN effect of PUR may correlate with ECM. Experimental validation suggested that PUR treatment could inhibit the generation of ECM to alleviate high-glucose-induced cell impairments, suppressing ROS production and excessive collagen fiber accumulation in GMSs, and reduce mesangial matrix expansion and renal fibrosis in type 2 DN rats. Further study suggested that PUR protected GMCs against ferroptosis via reducing LDH release and GSH disruption, suppressing key regulators of two pathways for ferroptosis execution. Moreover, PUR also maintained iron metabolism hemostasis by regulating iron transportation proteins, iron exporter proteins, and iron storage proteins and reducing intracellular iron in type 2 DN rats.

CONCLUSION:

PUR inhibited excessive ECM accumulation to protect against type 2 diabetic nephropathy, which meditated by regulating iron homeostasis and mitigating ferroptosis. This study provides promising therapeutics for diabetic nephropathy treatment.

News (Medical) associated with Institute of Materia Medica

30 May 2024

·www.prnewswire.com

State-of-the-Art Fertility Clinic Opens in Walnut Creek

Collab Fertility Helps People Grow Their Families with Evidence-based Treatment Backed by Compassionate and Streamlined Patient Care WALNUT CREEK, Calif., May 30, 2024 /PRNewswire/ -- With 15 percent of couples in the US experiencing fertility problems, a new state-of-the-art fertility clinic addresses the need for expert fertility care in the East Bay. Founded by fertility specialist Dr. Thalia Segal, Collab Fertility provides scientifically advanced fertility treatment. Dr. Segal is double board-certified in Reproductive Endocrinology and Infertility and Obstetrics and Gynecology and is known for her deep commitment to her patients. "We are an expert team of doctors, nurses, and scientists passionate about research and evidence-based fertility treatments. We are also down-to-earth people who care about our patients. We are thrilled to serve the greater East Bay community and help people welcome babies into their lives," says Dr. Segal. Dr. Segal and leadership staff, Xinli Yang, Lab Director; Rhodel Simbulan, Lab Supervisor; Anna Lopez, Clinical Operations Manager; and Mary Bennett, Finance/HR Manager, have many decades of experience in fertility care and reproductive sciences. The clinic provides comprehensive fertility services for heterosexual couples and LGBTQ+ couples, single moms and dads by choice, and people wishing to preserve their fertility before cancer treatment. Collab partners with reproductive psychologists, genetic counselors, nutritionists, and legal services to offer personalized support. Working closely with each patient, the Collab team crafts individualized treatment plans with the best chance of success. On-site services include: Same-day fertility testing Genetic carrier screening and genetic counseling Fertility preservation, including egg and embryo freezing In-vitro fertilization (IVF) Intrauterine insemination (IUI) Assistance securing donor sperm, donor eggs, and gestational carriers Collab's lab has cutting-edge equipment to ensure an optimized environment for oocytes, sperm, and embryos. The lab utilizes LifeAire®, an advanced air purification system, has 24/7 security cameras, multiple alarms tracking equipment performance, and a generator. ABOUT COLLAB FERTILITY Founded by Dr. Thalia Segal, Collab Fertility is a state-of-the-art fertility clinic in Walnut Creek, California. Collab's team of leading fertility experts provide comprehensive testing and treatments uniquely tailored to each patient. Its world-class laboratory is equipped with cutting-edge systems and technology, ensuring the utmost protection for eggs and embryos. Collab prioritizes fostering a safe and supportive atmosphere characterized by compassionate and streamlined communication. The staff celebrates and welcomes all family structures. SOURCE Collab Fertility

100 Deals associated with Institute of Materia Medica

100 Translational Medicine associated with Institute of Materia Medica

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Pipeline Snapshot as of 27 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Bicyclol ( HSP70 heat-shock proteins x PKC )	Hepatitis B More	Approved
Meisoindigo ( STAT3 )	Neoplasms More	Approved
Buagafuran	Generalized anxiety disorder More	Phase 3
Higenamine Hydrochloride ( β2-adrenergic receptor )	Coronary Artery Disease More	Phase 3
L-clausenamide ( APP )	Memory Disorders More	Phase 2

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