A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Single Dose Regimen Study of LMN-101 in Healthy Volunteers Challenged With Campylobacter Jejuni
Overview
- Phase
- Phase 2
- Intervention
- LMN-101
- Conditions
- Campylobacter Infections
- Sponsor
- Lumen Bioscience, Inc.
- Enrollment
- 42
- Locations
- 1
- Primary Endpoint
- Number of Participants With Solicited or Unsolicited Adverse Events
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief Summary
Randomized, double-blind, placebo-controlled, single dose regimen study of LMN-101 followed by Campylobacter jejuni challenge. Subjects will initially, after documentation of informed consent, begin taking their assigned LMN-101 or placebo regimen three times daily. After two days, subjects will receive the C. jejuni challenge inoculum. Subjects will begin an appropriate antibiotic course upon meeting early treatment criteria or 144 hours following C. jejuni challenge, whichever is earlier. Subjects will be allowed to leave the clinical research facility 3 days after antibiotics, when all symptoms have resolved or are resolving, and have had ≥ 2 consecutive stool cultures ≥ 12 hours apart negative for C. jejuni and are afebrile > 24 hours prior to release and off antipyretics within 24 hours of discharge. Subjects will continue taking their LMN-101 or placebo regimen three times daily for a total of 14 days. Subjects will be provided a diary card/memory aid and thermometer for at-home monitoring of solicited adverse events through Day 24. Subjects will be seen at research facility for protocol-specified evaluations and will also be contacted by telephone 6 months after challenge.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of informed consent
- •Willingness to participate after written informed consent obtained
- •Available for all planned clinical visits (for physical examinations, blood draws, and stool collections) and follow-up monitoring (9 or 10 clinic visits and 1 phone interview 6 months post-challenge)
- •Agreement to follow the restrictions of the study. Willing and able to follow the study directions and procedures, including the rules and procedures of the clinical research unit.
- •Demonstrated comprehension of the protocol procedures including knowledge of Campylobacter illness by passing a written examination (passing grade ≥ 70%).
- •General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
- •Laboratory values are Grade 1 or lower using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 as defined below:
- •Absolute neutrophil count ≥ 1500/μL
- •Lymphocyte count ≥ 800/μL
- •Platelet count ≥ 125,000/μL
Exclusion Criteria
- Not provided
Arms & Interventions
3000-mg cohort
LMN-101, six 500-mg capsules orally three times daily for 14 days (n=21)
Intervention: LMN-101
Placebo cohort
Placebo, six 500-mg capsules orally three times daily for 14 days (n=21)
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Participants With Solicited or Unsolicited Adverse Events
Time Frame: Day 1 to Day 14
Number of participants with solicited or unsolicited adverse events that received LMN-101 compared to placebo for the protocol-specified duration of collection for each type of adverse event.