A Study of Intranasal LMN-1001 in Healthy Adults
ConditionViral Infections
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLumen Bioscience, Inc.
About this trial
The purpose of this study is to optimize the tolerability of LMN-1001 relative to its ability to activate the host immune response. LMN-1001 is an investigational dry powder containing recombinant interferon lambda (IFN-λ).
Researchers will monitor side effects, vital signs, nasal symptoms, physical examination findings, and laboratory test results. Nasal and blood samples will be collected to determine how long LMN-1001 remains in the nose, whether it reaches the bloodstream, whether the body produces antibodies against it, and whether it causes local or whole-body immune responses. Participants will be followed through Day 28.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Male and female adults aged > 18 and < 65 years at screening
Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2, with a maximum body weight of 120 kg at screening
General good health, without significant medical illness or abnormal physical examination, or laboratory findings per PI discretion
Willing and able to comply with all study activities, assessments, and restrictions through 28 days of follow-up, have provided written informed consent to participate in the clinical trial before any study-related activities are carried out, and, in the PI's opinion, able to understand the full nature and purpose of the trial, including possible risks and adverse effects
Disqualifiers
History or presence of clinically significant medical condition or disease, including (but not limited to) clinically significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological or psychiatric disease
Any acute illness or surgery within the past 12 weeks prior to screening determined by the PI to be clinically relevant
Known allergy or previous anaphylaxis to any components of the study product
Allergies, a history of allergic conditions, nasal or sinus conditions, upper respiratory conditions, or chronic respiratory conditions, including seasonal allergies and mild asthma (history of childhood asthma or childhood allergies are not exclusionary)
Trial design
Design model
Sequential
Treatments tested in this trial
LMN-1001
Biological/VaccineIntranasal Interferon Lambda
Treatment groups
36 Participants
are divided into 5 treatment groupsGroup A: LMN-1001 single low doseExperimental treatment 1 intervention
Group B: LMN-1001 single medium doseExperimental treatment 1 intervention
Group C: LMN-1001 single high doseExperimental treatment 1 intervention
Group D: LMN-1001 multiple dose dailyExperimental treatment 1 intervention
Group E: LMN-1001 every other day dosingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The number of solicited AEs and SAEs
All adverse events (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 serious adverse events (SAEs), TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings.
Time frame
Through Day 142
Number of unsolicited AEs and SAEs
All adverse events (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 serious adverse events (SAEs), TEAEs leading to death or study withdrawal. The duration of all AEs will be determined and included in the listings.
Time frame
Through Day 143
Changes from baseline for systolic and diastolic blood pressure
Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics
Time frame
Through day 14.4
Changes from baseline for pulse rate
Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.
Time frame
Through day 14.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: