Topics

Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers

2019-09-26 05:42:39 | BioPortfolio

Summary

This will be a randomized, double-blind, placebo-controlled, dose-escalation study of 3 dose levels of LMN-101. Healthy volunteers will take LMN-101 or placebo orally at one of three dose levels three times daily over 28 days. Protocol-specified evaluations and procedures will be performed on Days 1-2 and every one-two weeks during dosing. Study observation will continue until 4 weeks after the last dose of study drug.

Description

Healthy volunteers will be sequentially assigned to the following dosing regimens and will be randomized within that dose regimen to active or placebo treatment:

- 300 mg PO TID (three times daily) given as a single 300-mg capsule of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsule (2 subjects).

- 1000 mg PO TID given as two 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects).

- 3000 mg PO TID given as six 500-mg capsules of LMN-101 orally three times daily for 28 days (4 subjects) or identical-appearing placebo capsules (2 subjects).

The primary endpoint is:

• Safety and tolerability of LMN-101.

The secondary endpoints are:

- Peak serum drug concentration following administration of the initial dose and peak serum drug concentration following a course of treatment (if systemic absorption is observed).

- Area under the serum drug concentration versus time curve (AUC) following administration of the initial dose and following a course of treatment (if systemic absorption is observed).

- Induction of serum anti-drug antibodies (if systemic absorption is observed).

Study Design

Conditions

Campylobacter Jejuni Infection

Intervention

LMN-101

Status

Not yet recruiting

Source

Lumen Bioscience, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-26T05:42:39-0400

Clinical Trials [399 Associated Clinical Trials listed on BioPortfolio]

Campylobacter Jejuni Challenge Model Development: Assessment of Homologous Protection

The goal of this research is to continue to develop a model of infection with Campylobacter jejuni, a bacterium that causes food and water-borne disease (mainly diarrhea). The objectives ...

LMN-101 in a Campylobacter Human Challenge Model

Randomized, double-blind, placebo-controlled study of three dose cohorts of LMN-101 followed by campylobacter challenge. Subjects will begin taking their LMN-101 or placebo regimen 3x dail...

Mucosal and Microbiota Changes During Acute Campylobacteriosis

Gastrointestinal (GI) infection with Campylobacter causes inflammation in the bowel and can change bacteria in the gut. Certain individuals with Campylobacter infection are also known to d...

Evaluation of a Diagnostic Enteric Card for Management of Diarrhea

PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mort...

Evaluation of Immunochromatographic Tests for Campylobacter Detection in Stools

For a long time, culture was the only way to detect Campylobacter. It appears that rapid immunochromatographic tests (ICT) have detected more positive cases compared to culture, ELISA and...

PubMed Articles [6343 Associated PubMed Articles listed on BioPortfolio]

In ovo vaccination of broilers against Campylobacter jejuni using a bacterin and subunit vaccine.

Campylobacter jejuni and Campylobacter coli originating from poultry meat have been the most important causes of foodborne bacterial gastroenteritis in the European Union since 2005. In-feed applicati...

Investigating the influence of iron on Campylobacter jejuni transcriptome in response to acid stress.

The capacity of C. jejuni to survive acid and capture iron is a requirement for C. jejuni to colonize host and cause infection. Herein, we aimed to characterize the influence of iron on Campylobacter ...

Source attribution of Campylobacter jejuni shows variable importance of chicken and ruminants reservoirs in non-invasive and invasive French clinical isolates.

Campylobacter jejuni is the most common cause of bacterial gastroenteritis worldwide. Mainly isolated from stool samples, C. jejuni can also become invasive. C. jejuni belongs to the commensal microbi...

Growth in the presence of specific antibiotics induces biofilm formation a Campylobacter jejuni strain sensitive to them but not in resistant strains.

Campylobacter jejuni are among the most frequently identified bacteria associated with human gastroenteritis worldwide. Exposure to antibiotics may induce or inhibit biofilm formation in some bacteria...

Prevalence of Campylobacter jejuni and Campylobacter coli from broilers at conventional and kosher abattoirs and retail stores.

We studied and compared the prevalence of Campylobacter jejuni and Campylobacter coli in chicken carcasses from conventional and kosher broiler abattoirs and retail stores. The prevalence of thermotol...

Medical and Biotech [MESH] Definitions

A species of bacteria that resemble small tightly coiled spirals. Its organisms are known to cause abortion in sheep and fever and enteritis in man and may be associated with enteric diseases of calves, lambs, and other animals.

A species of CAMPYLOBACTER isolated from DOGS; CATS; and humans.

A species of thermophilic CAMPYLOBACTER found in healthy seagulls and causing ENTERITIS in humans.

A species of CAMPYLOBACTER isolated from cases of human PERIODONTITIS. It is a microaerophile, capable of respiring with OXYGEN.

A species of CAMPYLOBACTER comprised of three biovars based on their reaction to CATALASE and UREASE. They have been isolated from humans, CATTLE, and SHEEP.

More From BioPortfolio on "Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers"

Quick Search

Relevant Topics

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...


Searches Linking to this Trial