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A Phase 1a Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Nezavist in Healthy Adults

The goal of this clinical trial is to determine the safety, tolerability and effects of Nezavist in healthy adults. The main questions it aims to answer are:
* What is the safety and maximum tolerated dose (MTD) of orally administered Nezavist formulated as a spray dried dispersion (SDD) in healthy volunteers?
* What are the pharmacokinetics (PK) of orally administered Nezavist SDD and its major metabolite (DCUKA) across a range of doses in healthy volunteers?
Researchers will compare the active drug (Nezavist) and a placebo (an inactive substance that looks like the drug) to see if there is any differences between the two groups to make sure Nezavist is safe to use in future studies for reducing alcohol consumption by individuals that have alcohol use disorder (AUD).

开始日期2025-01-01

申办/合作机构

Lohocla Research Corp.

[+1]

NCT06243835 / Recruiting临床1期

A Phase 1a Randomized, Double-blind, Placebo-controlled, Single Site, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Kindolor Tosylate in Healthy Adults

The goal of this study is to test Kindolor in healthy adults. The main questions it aims to answer are:
* What is the safe dose of Kindolor in healthy volunteers?
* How is Kindolor metabolized by the human body?
Participants will undergo medical tests before and after receiving Kindolor or a placebo to see if there is any difference between the groups.

开始日期2024-04-21

申办/合作机构

Lohocla Research Corp.

[+1]

100 项与 Lohocla Research Corp. 相关的临床结果

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0 项与 Lohocla Research Corp. 相关的专利（医药）

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7

项与 Lohocla Research Corp. 相关的文献（医药）

2020-01-01·Journal of Psychiatry and Brain Science

Controlling the “Opioid Epidemic”: A Novel Chemical Entity (NCE) to Reduce or Supplant Opiate Use for Chronic Pain

Article

作者: Hoffman, Paula L ; Tabakoff, Boris

We report on the ongoing project "A Novel Therapeutic to Ameliorate Chronic Pain and Reduce Opiate Use." Over 100 million adults in the U.S. suffer from intermittent or constant chronic pain, and chronic pain affects at least 10% of the world's population. The primary pharmaceuticals for treatment of chronic pain have been natural or synthetic opioids and the use of opioids for pain treatment has resulted in what has been called an "epidemic" of opioid abuse, addiction and lethal overdoses. We have, through a process of rational drug design, generated a novel chemical entity (NCE) and have given it the name Kindolor. Kindolor is a non-opiate, non-addicting molecule that was developed specifically to simultaneously control the aberrant activity of three targets on the peripheral sensory system that are integral in the development and propagation of chronic pain. In our initial preclinical studies, we demonstrated the efficacy of Kindolor to reduce or eliminate chronic pain in five animal models. The overall goal of the project is to complete the investigational new drug (IND)-enabling preclinical studies of Kindolor, and once IND approval is gained, we will proceed to the clinical Phase Ia and 1b safety studies and a Phase 2a efficacy study. The work is in its second year, and the present report describes progress toward our overall goal of bringing our compound to a full Phase 2 ready stage.

2016-08-01·European Journal of Pharmacology3区 · 医学

A novel substituted aminoquinoline selectively targets voltage-sensitive sodium channel isoforms and NMDA receptor subtypes and alleviates chronic inflammatory and neuropathic pain

3区 · 医学

Article

作者: Snell, Lawrence D ; Levinson, Rock ; Rush, Anthony M ; Ren, Wenhua ; Honse, Yumiko ; Gustafson, Daniel L ; Lovinger, David ; Smothers, C Thetford ; Woodward, John J ; Matheson, Christopher J ; Wang, Ze-Jun ; Sather, William A ; Vanderlinden, Lauren ; Hoffman, Paula L ; Tabakoff, Boris

Recent understanding of the systems that mediate complex disease states, has generated a search for molecules that simultaneously modulate more than one component of a pathologic pathway. Chronic pain syndromes are etiologically connected to functional changes (sensitization) in both peripheral sensory neurons and in the central nervous system (CNS). These functional changes involve modifications of a significant number of components of signal generating, signal transducing and signal propagating pathways. Our analysis of disease-related changes which take place in sensory neurons during sensitization led to the design of a molecule that would simultaneously inhibit peripheral NMDA receptors and voltage sensitive sodium channels. In the current report, we detail the selectivity of N,N-(diphenyl)-4-ureido-5,7-dichloro-2-carboxy-quinoline (DCUKA) for action at NMDA receptors composed of different subunit combinations and voltage sensitive sodium channels having different α subunits. We show that DCUKA is restricted to the periphery after oral administration, and that circulating blood levels are compatible with its necessary concentrations for effects at the peripheral cognate receptors/channels that were assayed in vitro. Our results demonstrate that DCUKA, at concentrations circulating in the blood after oral administration, can modulate systems which are upregulated during peripheral sensitization, and are important for generating and conducting pain information to the CNS. Furthermore, we demonstrate that DCUKA ameliorates the hyperalgesia of chronic pain without affecting normal pain responses in neuropathic and inflammation-induced chronic pain models.

2015-05-05·Oxford Handbooks Online

Biological Markers of Substance Use

作者: Boris Tabakoff ; Laszlo Takacs ; Lawrence D. Snell ; Sanjiv V. Bhave

Ascertaining an individual’s history of alcohol consumption is an important component in the proper treatment of accidental trauma or acute or chronic illness, as well as for matters of public health and safety, legal issues, insurance coverage, and the management of and recovery from hazardous/harmful levels of alcohol consumption. Although self-report of alcohol consumption in both research and clinical settings represents the most common mode of assessment, there is long-standing interest in developing objective measures of alcohol consumption that do not rely on the ability or willingness of a person to truthfully report consumption. Biologic diagnostic tests or biomarkers can provide information on current and past quantity and frequency of alcohol consumption. This chapter discusses and evaluates many of the biomarker candidates that have been investigated and provides insights into future searches for optimal diagnostic tools to provide biologic evidence of duration, quantity, and frequency of individual alcohol consumption. We have included a limited discussion of biomarkers for assessing cannabis use since cannabis and alcohol use many times are a concomitant feature of intoxication.

100 项与 Lohocla Research Corp. 相关的药物交易

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100 项与 Lohocla Research Corp. 相关的转化医学

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当前项目

药物(靶点)	适应症	全球最高研发状态

Nezavist	-	临床1期
Lohocla 201 ( NMDA receptor x Nav1.7 x Nav1.8 x δ opioid receptor )	慢性疼痛更多	临床1期
LOH-100	神经系统疾病更多	临床前
mol-BCUKA	-	终止