Campylobacter Jejuni Infection Clinical Trial
Official title:
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
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 either as a single dose or 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:
Part A:
A single, open-label dose of 3000 mg orally (2 subjects)
Part B:
Subjects will be randomized within a 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).
;