[Translation] A single-center, open-label, self-controlled study evaluating the interaction between MY004567 tablets and methotrexate tablets in healthy adult subjects

主要目的：评估MY004567片对健康成年受试者口服甲氨蝶呤片的药代动力学（PK）特征的影响。次要目的：评估健康成年受试者口服MY004567片和甲氨蝶呤片后的安全性。

[Translation]

Primary objective: To evaluate the effect of MY004567 tablets on the pharmacokinetic (PK) characteristics of oral methotrexate tablets in healthy adult subjects. Secondary objective: To evaluate the safety of MY004567 tablets and methotrexate tablets after oral administration in healthy adult subjects.

Start Date05 Apr 2023

Sponsor / Collaborator

Shanghai Meiyue Biotech Development Co. Ltd.

CTR20222675 / CompletedPhase 1

一项在健康成年受试者中评价食物对MY004567片的药代动力学特征影响的开放、随机、单剂量、双交叉研究

[Translation] An open-label, randomized, single-dose, double-crossover study to evaluate the effect of food on the pharmacokinetic profile of MY004567 tablets in healthy adult subjects

主要目的：评估食物对健康成年受试者单次口服MY004567片的药代动力学（PK）特征的影响。次要目的：评估食物对健康成年受试者单次口服MY004567片安全性的影响。

[Translation]

Primary objective: To evaluate the effect of food on the pharmacokinetic (PK) characteristics of a single oral dose of MY004567 tablets in healthy adult subjects. Secondary objective: To evaluate the effect of food on the safety of a single oral dose of MY004567 tablets in healthy adult subjects.

Start Date04 Jan 2023

Sponsor / Collaborator

Shanghai Meiyue Biotech Development Co. Ltd.

CTR20222849 / CompletedPhase 1

一项评估MY004567片80 mg多次给药在健康成年受试者中的安全性、耐受性和药代动力学特征的随机、双盲的I期临床试验

[Translation] A randomized, double-blind, phase I clinical trial to evaluate the safety, tolerability, and pharmacokinetic characteristics of multiple doses of 80 mg MY004567 tablets in healthy adult subjects

主要目的：评估MY004567片80 mg多次给药在健康成年受试者中的安全性和耐受性。次要目的：评估MY004567片80 mg多次给药在健康成年受试者中的药代动力学（PK）特征。探索性目的：探索人体血浆中代谢产物的类型。尝试对主要代谢产物进行定量研究。初步探索MY004567片80 mg多次给药时在健康成年受试者中的药效动力学（PD）特征。

[Translation]

Primary objective: To evaluate the safety and tolerability of MY004567 tablets 80 mg multiple dosing in healthy adult subjects. Secondary objective: To evaluate the pharmacokinetic (PK) characteristics of MY004567 tablets 80 mg multiple dosing in healthy adult subjects. Exploratory objective: To explore the types of metabolites in human plasma. To attempt to quantitatively study the main metabolites. To preliminarily explore the pharmacodynamic (PD) characteristics of MY004567 tablets 80 mg multiple dosing in healthy adult subjects.

Start Date09 Nov 2022

Sponsor / Collaborator

Shanghai Meiyue Biotech Development Co. Ltd.

100 Clinical Results associated with Nacresertib

100 Translational Medicine associated with Nacresertib

100 Patents (Medical) associated with Nacresertib

Literatures (Medical) associated with Nacresertib

01 Aug 1999·Infection and ImmunityQ2 · MEDICINE

Anti-CD14 Monoclonal Antibodies Inhibit the Production of Tumor Necrosis Factor Alpha and Interleukin-10 by Human Monocytes Stimulated with Killed and LiveHaemophilus influenzaeorStreptococcus pneumoniaeOrganisms

Q2 · MEDICINE

Article

Author: Langermans, Jan A. M. ; van Furth, A. Marceline ; van Dissel, Jaap T. ; Verhard-Seijmonsbergen, Els M. ; van Furth, Ralph

ABSTRACTIn previous studies, we have shown that intact, heat-killed, gram-negative bacteria (GNB) and gram-positive bacteria (GPB) can stimulate the production of various proinflammatory and anti-inflammatory cytokines. The objective of the present study was to investigate whether the production of tumor necrosis factor alpha (TNF) and interleukin-10 (IL-10) by human monocytes stimulated by intact heat-killed or liveHaemophilus influenzaeorStreptococcus pneumoniaeis mediated by CD14. Two anti-CD14 monoclonal antibodies (MAbs) were used to study the interaction between human monocytes and bacteria; lipopolysaccharide (LPS) was used to validate the effect of anti-CD14 MAb. MAb 18E12 decreased significantly TNF and IL-10 production upon stimulation with LPS or heat-killed bacteria and TNF production during stimulation by live bacteria. MAb My-4 decreased production of TNF and IL-10 by monocytes stimulated with LPS, IL-10 but not TNF production upon stimulation with heat-killedH. influenzae, and production of neither TNF nor IL-10 upon stimulation withS. pneumoniae. Together, these results led to the conclusion that CD14 is involved in the recognition and stimulation of human monocytes by intact GNB and GPB. Consequentially, the option for adjunctive treatment of severe infections with anti-CD14 MAb is postulated.

100 Deals associated with Nacresertib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	CN	Shanghai Meiyue Biotech Development Co. Ltd.	16 Jun 2023
Dermatitis, Atopic	Phase 2	-	Wuhan Createrna Science and Technology Co.,Ltd.	-
Psoriasis	Phase 2	-	Wuhan Createrna Science and Technology Co.,Ltd.	-
Systemic Lupus Erythematosus	Phase 2	-	Wuhan Createrna Science and Technology Co.,Ltd.	-
Glomerulonephritis, IGA	IND Approval	CN	Wuhan Createrna Science and Technology Co.,Ltd.	12 Jan 2024

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