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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.
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).
Campylobacter Jejuni Infection
Not yet recruiting
Lumen Bioscience, Inc.
Published on BioPortfolio: 2019-09-26T05:42:39-0400
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 ...
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...
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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.
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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...