A Study to Determine the Tolerability of Intranasal LMN-301
- Conditions
- COVID-19
- Interventions
- Biological: LMN-301
- Registration Number
- NCT06030414
- Lead Sponsor
- Lumen Bioscience, Inc.
- Brief Summary
LMN-301 is to prevent infection by SARS-CoV-2 (the virus causing Covid-19 disease) in uninfected individuals. This study aims to assess whether the formulation will cause irritation when administered in the nose, and how long its protective effects will last.
Thirty five healthy adult volunteers will participate in this study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Main Cohort Group 1 LMN-301 - Main Cohort Group 2 LMN-301 - Sentinel Cohort LMN-301 - Main Cohort Group 3 LMN-301 -
- Primary Outcome Measures
Name Time Method Number of participants discontinuing from the study For 28 days after the first dose of LMN-301 The number of participants discontinuing from the study and the reason for discontinuation will be summarized.
Changes from baseline vital sign measures (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate) In part A vital signs are measured on Days 1 (5 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (5 timepoints), 3 or 4, 7, 10 or 11, 14 and 28. Observed values and changes from baseline for vital signs (systolic and diastolic blood pressure, pulse rate, oral temperature, and respiratory rate) will be summarized at each scheduled timepoint using descriptive statistics.
Changes from baseline safety laboratory measures (hematology, clinical chemistry and coagulation) For Part A on Days 1, 2, 8 and 14 and For Part B on Days 1, 3 or 4, 7, 14 and 28 Clinical laboratory safety data will be summarized by laboratory measure (hematology, clinical chemistry and coagulation). Observed values and changes from baseline for continuous clinical laboratory parameters will be summarized at each scheduled timepoint using descriptive statistics. Categorical clinical laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. The clinical assessment of laboratory data will be summarized at each scheduled timepoint using participant counts and percentages. Individual participant profiles will be presented for any laboratory parameters with at least one post-dose value outside the laboratory's reference ranges that is deemed clinically significant.
Changes from baseline nasal symptoms using the Sino-Nasal Outcome Test (total score) For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28 Scores will be totaled for all 22 symptoms. Changes from baseline in individual total SNOT-22 scores will be calculated as the post-baseline value minus the baseline value. Thus, a negative change will reflect an improvement in the corresponding score. Observed values and changes from baseline will be summarized at each scheduled timepoint by treatment using descriptive statistics and tabulated for each cohort (dose level) and overall.
Individual symptoms will be listed, with the 5 most important issues flagged. The total SNOT score will also be included in the listing.Occurrence of adverse events as assessed by CTCAE v5.0 for 28 days after the first dose of LMN-301 Daily for 28 days All AEs will be coded using the latest version of MedDRA by system organ class (SOC) and preferred term, classified from verbatim terms. The number of treatment-emergent AEs (TEAEs) as well as the number and percentage of participants with at least one TEAE, will be summarized by SOC and preferred term. Summaries of TEAEs by severity as assessed by CTCAE v5.0 and relationship will also be presented. Summaries will also be presented for SAEs, TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings. Solicited and unsolicited TEAEs will be summarized separately.
Changes from baseline ECG parameters (PR interval, QRS duration, QTcB, QTcF and ventricular heart rate) Screening and Day 14 The following ECG parameters will be analyzed: PR interval, QRS duration, QTcB, QTcF and ventricular heart rate. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.
For QTcF, the number of participants with values greater than 450 (and 480, 500) msec or an increase from baseline of at least 30 (and 60) msec will also be tabulated, in accordance with ICH E14
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia