Phase 1
N=21
Safety and Pharmacokinetic Study of LMN-101 in Healthy Volunteers
Campylobacter Jejuni Infection
Bottom Line
View on ClinicalTrials.gov: NCT04098263 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Count of Participants With Adverse Events — 0; 1; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LMN-101 (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lumen Bioscience, Inc.
- Primary completion
- Apr 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants With Adverse Events |
0; 1; 3; 1; 3 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- Male or female between 18 and 50 years, 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, stool collections
- General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
- Adequate bone marrow reserve, renal and liver function.
- Absolute neutrophil count ≥ 1.5 x 10e9/L
- Lymphocyte count 170 mmHg or diastolic blood pressure > 110 mmHg).
- History of venous thromboembolic disease within 12 months, myocardial infarction, or cerebrovascular accident.
- Unstable pulmonary, renal, hepatic, endocrine or hematologic disease.
- Gastrointestinal disorder requiring ongoing care by a physician.
- Autoimmune disease, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis.
- Evidence of active malignant disease, malignancies diagnosed within the previous 5 years, or breast cancer diagnosed within the previous 5 years (except skin cancers other than melanoma).
- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other opportunistic infections; or major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks.
- Positive serology for human immunodeficiency virus (HIV) infection or history of other immunodeficiency illness.
- Positive serology results for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
- Significant neuromuscular disease or neuropathy
- Psychiatric condition
- Alcohol or illicit drug abuse/dependency or positive urine toxicology screen for drugs of abuse other than marijuana. Alcohol and tobacco consumption are permitted.
Data sourced from ClinicalTrials.gov (NCT04098263). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.