Trial Outcomes & Findings for A Study to Determine the Tolerability of Intranasal LMN-301 (NCT NCT06030414)

Last Updated: 2025-07-30

Results Overview

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. Solicited and unsolicited TEAEs will be summarized separately.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

35 participants

Primary outcome timeframe

Daily for 28 days

Results posted on

2025-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Sentinel Cohort Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Overall Study STARTED	5	10	10	10
Overall Study COMPLETED	5	10	9	10
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Determine the Tolerability of Intranasal LMN-301

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)	Total n=35 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	10 Participants n=7 Participants	10 Participants n=5 Participants	10 Participants n=4 Participants	35 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	29.4 years STANDARD_DEVIATION 15.66 • n=5 Participants	40.6 years STANDARD_DEVIATION 16.32 • n=7 Participants	37.9 years STANDARD_DEVIATION 14.63 • n=5 Participants	33.8 years STANDARD_DEVIATION 14.33 • n=4 Participants	37.4 years STANDARD_DEVIATION 14.86 • n=21 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	8 Participants n=4 Participants	20 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	9 Participants n=7 Participants	9 Participants n=5 Participants	7 Participants n=4 Participants	30 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	5 Participants n=4 Participants	22 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment Australia	5 participants n=5 Participants	10 participants n=7 Participants	10 participants n=5 Participants	10 participants n=4 Participants	35 participants n=21 Participants

PRIMARY outcome

Timeframe: Daily for 28 days

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Number of Participants With Adverse Events	5 Participants	9 Participants	10 Participants	8 Participants

PRIMARY outcome

Timeframe: For 28 days after the first dose of LMN-301

The endpoint is the number of participants discontinuing from the study.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Number of Participants Discontinuing From the Study	0 Participants	0 Participants	1 Participants	0 Participants

PRIMARY outcome

Timeframe: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.

Changes from baseline for systolic and diastolic blood pressure will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

PRIMARY outcome

Timeframe: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.

Changes from baseline for pulse rate will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 1, 0.25 hour post-dose	—	-4.2 Change from baseline of pulse rate Standard Deviation 7.51	-5.0 Change from baseline of pulse rate Standard Deviation 3.32	-3.0 Change from baseline of pulse rate Standard Deviation 4.11
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 1, 0.5 hour post-dose	-4.8 Change from baseline of pulse rate Standard Deviation 3.27	-5.4 Change from baseline of pulse rate Standard Deviation 6.40	-4.6 Change from baseline of pulse rate Standard Deviation 2.99	-4.0 Change from baseline of pulse rate Standard Deviation 5.98
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 1, 1 hour post-dose	-7.0 Change from baseline of pulse rate Standard Deviation 1.87	-3.0 Change from baseline of pulse rate Standard Deviation 8.70	-4.0 Change from baseline of pulse rate Standard Deviation 4.59	-5.0 Change from baseline of pulse rate Standard Deviation 5.08
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 1, 4 hours post-dose	1.4 Change from baseline of pulse rate Standard Deviation 2.70	3.1 Change from baseline of pulse rate Standard Deviation 7.80	3.1 Change from baseline of pulse rate Standard Deviation 4.23	2.6 Change from baseline of pulse rate Standard Deviation 7.21
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 2 post-dose	3.4 Change from baseline of pulse rate Standard Deviation 7.27	—	—	—
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 3 post-dose	—	0 Change from baseline of pulse rate Standard Deviation 0	2.7 Change from baseline of pulse rate Standard Deviation 7.12	-1.8 Change from baseline of pulse rate Standard Deviation 4.21
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 4 post-dose	—	-0.5 Change from baseline of pulse rate Standard Deviation 6.26	0 Change from baseline of pulse rate Standard Deviation 0	0 Change from baseline of pulse rate Standard Deviation 0
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 7 post-dose	—	5.0 Change from baseline of pulse rate Standard Deviation 10.12	8.3 Change from baseline of pulse rate Standard Deviation 8.29	0.8 Change from baseline of pulse rate Standard Deviation 8.05
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 8 post-dose	3.4 Change from baseline of pulse rate Standard Deviation 8.29	—	—	—
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 10 post-dose	—	5.4 Change from baseline of pulse rate Standard Deviation 11.1	0 Change from baseline of pulse rate Standard Deviation 0	0 Change from baseline of pulse rate Standard Deviation 0
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 11 post-dose	—	0 Change from baseline of pulse rate Standard Deviation 0	6.3 Change from baseline of pulse rate Standard Deviation 4.85	-2.0 Change from baseline of pulse rate Standard Deviation 3.33
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 14 post-dose	4.6 Change from baseline of pulse rate Standard Deviation 8.32	3.2 Change from baseline of pulse rate Standard Deviation 7.22	6.7 Change from baseline of pulse rate Standard Deviation 6.02	2.3 Change from baseline of pulse rate Standard Deviation 2.36
Changes From Baseline of Pulse Rate. Change from baseline in pulse rate (beats/min ) - Day 28 post-dose	—	1.5 Change from baseline of pulse rate Standard Deviation 6.67	-1.4 Change from baseline of pulse rate Standard Deviation 5.96	-1.5 Change from baseline of pulse rate Standard Deviation 7.31

PRIMARY outcome

Timeframe: In part A vital signs are measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.

Changes from baseline for oral temperature will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 1, 0.25 hour post-dose	—	-0.15 Change from baseline of temperature (°C) Standard Deviation 0.381	-0.04 Change from baseline of temperature (°C) Standard Deviation 0.388	0.13 Change from baseline of temperature (°C) Standard Deviation 0.347
Changes From Baseline of Oral Temperature. Change from baseline in temperature Change from baseline in (°C) - Day 1, 0.5 hour post-dose	-0.42 Change from baseline of temperature (°C) Standard Deviation 0.476	0.01 Change from baseline of temperature (°C) Standard Deviation 0.185	-0.1 Change from baseline of temperature (°C) Standard Deviation 0.613	0.17 Change from baseline of temperature (°C) Standard Deviation 0.460
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 1, 1 hour post-dose	-0.42 Change from baseline of temperature (°C) Standard Deviation 0.228	-0.11 Change from baseline of temperature (°C) Standard Deviation 0.805	-0.02 Change from baseline of temperature (°C) Standard Deviation 0.322	0.14 Change from baseline of temperature (°C) Standard Deviation 0.327
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 1, 4 hour post-dose	-0.10 Change from baseline of temperature (°C) Standard Deviation 0.418	0.13 Change from baseline of temperature (°C) Standard Deviation 0.313	-0.34 Change from baseline of temperature (°C) Standard Deviation 0.488	0.16 Change from baseline of temperature (°C) Standard Deviation 0.422
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 2 post-dose	-0.34 Change from baseline of temperature (°C) Standard Deviation 0.297	—	—	—
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 3 post-dose	—	0 Change from baseline of temperature (°C) Standard Deviation 0	-0.25 Change from baseline of temperature (°C) Standard Deviation 0.788	0.18 Change from baseline of temperature (°C) Standard Deviation 0.368
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 4 post-dose	—	-0.8 Change from baseline of temperature (°C) Standard Deviation 0.437	0 Change from baseline of temperature (°C) Standard Deviation 0	0 Change from baseline of temperature (°C) Standard Deviation 0
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 7 post-dose	—	-0.18 Change from baseline of temperature (°C) Standard Deviation 0.338	-0.10 Change from baseline of temperature (°C) Standard Deviation 0.424	0.27 Change from baseline of temperature (°C) Standard Deviation 0.350
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 8 post-dose	-0.34 Change from baseline of temperature (°C) Standard Deviation 0.658	—	—	—
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 10 post-dose	—	-0.17 Change from baseline of temperature (°C) Standard Deviation 0.374	0 Change from baseline of temperature (°C) Standard Deviation 0	0 Change from baseline of temperature (°C) Standard Deviation 0
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 11 post-dose	—	0 Change from baseline of temperature (°C) Standard Deviation 0	-0.10 Change from baseline of temperature (°C) Standard Deviation 0.274	0.17 Change from baseline of temperature (°C) Standard Deviation 0.353
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 14 post-dose	-0.32 Change from baseline of temperature (°C) Standard Deviation 0.653	-0.22 Change from baseline of temperature (°C) Standard Deviation 0.424	0.02 Change from baseline of temperature (°C) Standard Deviation 0.549	0.33 Change from baseline of temperature (°C) Standard Deviation 0.472
Changes From Baseline of Oral Temperature. Change from baseline in temperature (°C) - Day 28 post-dose	—	-0.18 Change from baseline of temperature (°C) Standard Deviation 0.394	-0.39 Change from baseline of temperature (°C) Standard Deviation 0.446	0.25 Change from baseline of temperature (°C) Standard Deviation 0.517

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Population: There are timepoints for sentinel cohort Part A that were not collected for main cohort Part B; because of this there are some timepoint collections listed as "0" subjects analyzed for that particular timepoint. Otherwise "0" has been entered where data was not collected for that timepoint.

Clinical laboratory safety data will be summarized by laboratory measures like hemoglobin. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 2	2.6 Changes from baseline of hemoglobin(g/L) Standard Deviation 10.04	—	—	—
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 3	—	0 Changes from baseline of hemoglobin(g/L) Standard Deviation 0	-2.8 Changes from baseline of hemoglobin(g/L) Standard Deviation 7.07	-1.3 Changes from baseline of hemoglobin(g/L) Standard Deviation 6.50
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 4	—	-1.5 Changes from baseline of hemoglobin(g/L) Standard Deviation 7.12	0 Changes from baseline of hemoglobin(g/L) Standard Deviation 0	0 Changes from baseline of hemoglobin(g/L) Standard Deviation 0
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 7	—	-0.6 Changes from baseline of hemoglobin(g/L) Standard Deviation 4.28	-9.3 Changes from baseline of hemoglobin(g/L) Standard Deviation 5.36	-4.7 Changes from baseline of hemoglobin(g/L) Standard Deviation 6.25
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 8	-0.8 Changes from baseline of hemoglobin(g/L) Standard Deviation 7.79	—	—	—
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 14	-2.2 Changes from baseline of hemoglobin(g/L) Standard Deviation 11.08	-3.2 Changes from baseline of hemoglobin(g/L) Standard Deviation 5.45	-5.4 Changes from baseline of hemoglobin(g/L) Standard Deviation 5.17	-3.8 Changes from baseline of hemoglobin(g/L) Standard Deviation 7.22
Changes From Baseline of Hemoglobin. Change from baseline in hemoglobin (g/L) Day 28	—	-4.7 Changes from baseline of hemoglobin(g/L) Standard Deviation 5.77	-4.9 Changes from baseline of hemoglobin(g/L) Standard Deviation 9.44	-2.7 Changes from baseline of hemoglobin(g/L) Standard Deviation 6.53

PRIMARY outcome

Timeframe: In part A respiratory rate is measured on Days 1 (4 timepoints), 2, 8 and 14. In part B vital signs are measured on Days 1 (3 timepoints), 3 or 4, 7, 10 or 11, 14 and 28.

Population: Healthy volunteers aged 18-65 years, BMI between 18.0 and 30.0 kg/m, and a maximum body weight of 120 kg.

Changes from baseline for respiratory rate will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 28 post-dose	—	-0.3 Respiratory rate (breaths per minute) Standard Deviation 2.00	-1.6 Respiratory rate (breaths per minute) Standard Deviation 2.40	-0.1 Respiratory rate (breaths per minute) Standard Deviation 1.85
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 1, 0.25 hours post-dose	—	-0.5 Respiratory rate (breaths per minute) Standard Deviation 2.88	-3.1 Respiratory rate (breaths per minute) Standard Deviation 2.67	-0.3 Respiratory rate (breaths per minute) Standard Deviation 1.16
Changes From Baseline of Respiratory Rate. Change from baseline in Respiratory Rate (breaths/minute) - Day 1, 0.5 hour post-dose	-3.6 Respiratory rate (breaths per minute) Standard Deviation 2.19	0.3 Respiratory rate (breaths per minute) Standard Deviation 2.58	-2.9 Respiratory rate (breaths per minute) Standard Deviation 2.33	0.3 Respiratory rate (breaths per minute) Standard Deviation 1.95
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 1, 1 hours post-dose	-0.8 Respiratory rate (breaths per minute) Standard Deviation 1.10	-1.0 Respiratory rate (breaths per minute) Standard Deviation 1.58	-1.8 Respiratory rate (breaths per minute) Standard Deviation 2.39	-0.6 Respiratory rate (breaths per minute) Standard Deviation 1.71
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 1, 4 hours post-dose	-0.8 Respiratory rate (breaths per minute) Standard Deviation 1.10	0.3 Respiratory rate (breaths per minute) Standard Deviation 1.77	-1.1 Respiratory rate (breaths per minute) Standard Deviation 1.79	1.4 Respiratory rate (breaths per minute) Standard Deviation 2.32
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 2 post-dose	-2.4 Respiratory rate (breaths per minute) Standard Deviation 1.67	—	—	—
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 3 post-dose	—	0 Respiratory rate (breaths per minute) Standard Deviation 0	-1.8 Respiratory rate (breaths per minute) Standard Deviation 3.08	-1.1 Respiratory rate (breaths per minute) Standard Deviation 1.60
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 4 post-dose	—	0.1 Respiratory rate (breaths per minute) Standard Deviation 1.79	0 Respiratory rate (breaths per minute) Standard Deviation 0	0 Respiratory rate (breaths per minute) Standard Deviation 0
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 7 post-dose	—	0.1 Respiratory rate (breaths per minute) Standard Deviation 1.27	-1.3 Respiratory rate (breaths per minute) Standard Deviation 1.73	0.1 Respiratory rate (breaths per minute) Standard Deviation 1.73
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 8 post-dose	-2.4 Respiratory rate (breaths per minute) Standard Deviation 1.67	—	—	—
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 10 post-dose	—	15.3 Respiratory rate (breaths per minute) Standard Deviation 1.41	0 Respiratory rate (breaths per minute) Standard Deviation 0	0 Respiratory rate (breaths per minute) Standard Deviation 0
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 11 post-dose	—	0 Respiratory rate (breaths per minute) Standard Deviation 0	-1.6 Respiratory rate (breaths per minute) Standard Deviation 2.13	1.3 Respiratory rate (breaths per minute) Standard Deviation 2.16
Changes From Baseline of Respiratory Rate. Change from baseline in respiratory rate (breaths/minute) - Day 14 post-dose	-1.6 Respiratory rate (breaths per minute) Standard Deviation 0.89	-1.1 Respiratory rate (breaths per minute) Standard Deviation 1.37	-2.0 Respiratory rate (breaths per minute) Standard Deviation 2.45	-1.3 Respiratory rate (breaths per minute) Standard Deviation 1.83

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures such as hematocrit. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 2	0.016 Hematocrit (g/L) Standard Deviation 0.0336	—	—	—
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 3	—	0 Hematocrit (g/L) Standard Deviation 0	-0.010 Hematocrit (g/L) Standard Deviation 0.0211	-0.008 Hematocrit (g/L) Standard Deviation 0.0217
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 4	—	-0.011 Hematocrit (g/L) Standard Deviation 0.0292	0 Hematocrit (g/L) Standard Deviation 0	0 Hematocrit (g/L) Standard Deviation 0
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 7	—	-0.006 Hematocrit (g/L) Standard Deviation 0.0167	-0.031 Hematocrit (g/L) Standard Deviation 0.0169	-0.016 Hematocrit (g/L) Standard Deviation 0.0232
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 8	0.006 Hematocrit (g/L) Standard Deviation 0.0270	—	—	—
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 14	0.000 Hematocrit (g/L) Standard Deviation 0.0381	-0.019 Hematocrit (g/L) Standard Deviation 0.0228	-0.017 Hematocrit (g/L) Standard Deviation 0.0141	-0.011 Hematocrit (g/L) Standard Deviation 0.0202
Changes From Baseline of Hematocrit. Change from baseline in hematocrit (L/L) Day 28	—	-0.013 Hematocrit (g/L) Standard Deviation 0.0216	-0.016 Hematocrit (g/L) Standard Deviation 0.0265	0.000 Hematocrit (g/L) Standard Deviation 0.0245

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures such as platelets. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 2	2.0 Platelets (10^9 cells/L) Standard Deviation 18.07	—	—	—
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 3	—	0 Platelets (10^9 cells/L) Standard Deviation 0	-5.4 Platelets (10^9 cells/L) Standard Deviation 18.87	-7.3 Platelets (10^9 cells/L) Standard Deviation 7.84
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 4	—	-4.4 Platelets (10^9 cells/L) Standard Deviation 12.67	0 Platelets (10^9 cells/L) Standard Deviation 0	0 Platelets (10^9 cells/L) Standard Deviation 0
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 7	—	0.9 Platelets (10^9 cells/L) Standard Deviation 22.77	-12.6 Platelets (10^9 cells/L) Standard Deviation 10.86	-9.2 Platelets (10^9 cells/L) Standard Deviation 11.52
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 8	8.4 Platelets (10^9 cells/L) Standard Deviation 16.64	—	—	—
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 14	-2.4 Platelets (10^9 cells/L) Standard Deviation 27.65	15.9 Platelets (10^9 cells/L) Standard Deviation 30.55	12.3 Platelets (10^9 cells/L) Standard Deviation 25.74	21.2 Platelets (10^9 cells/L) Standard Deviation 24.68
Change From Baseline in Platelets (10^9/L) Change from baseline in platelets (10^9/L) Day 28	—	1.8 Platelets (10^9 cells/L) Standard Deviation 34.30	-11.2 Platelets (10^9 cells/L) Standard Deviation 12.56	12.0 Platelets (10^9 cells/L) Standard Deviation 39.31

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like neutrophils. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 4	—	0.2 Neutrophils (10^9 cells/L) Standard Deviation 0.555	0 Neutrophils (10^9 cells/L) Standard Deviation 0	0 Neutrophils (10^9 cells/L) Standard Deviation 0
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 2	0.56 Neutrophils (10^9 cells/L) Standard Deviation 0.847	0 Neutrophils (10^9 cells/L) Standard Deviation 0	-0.33 Neutrophils (10^9 cells/L) Standard Deviation 0.602	0.43 Neutrophils (10^9 cells/L) Standard Deviation 0.817
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 3	—	0 Neutrophils (10^9 cells/L) Standard Deviation 0	-0.33 Neutrophils (10^9 cells/L) Standard Deviation 0.602	0.43 Neutrophils (10^9 cells/L) Standard Deviation 0.817
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 7	—	0.36 Neutrophils (10^9 cells/L) Standard Deviation 0.664	-0.34 Neutrophils (10^9 cells/L) Standard Deviation 1.181	2.06 Neutrophils (10^9 cells/L) Standard Deviation 1.465
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 8	-0.18 Neutrophils (10^9 cells/L) Standard Deviation 0.536	—	—	—
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 14	-0.38 Neutrophils (10^9 cells/L) Standard Deviation 0.838	0.27 Neutrophils (10^9 cells/L) Standard Deviation 1.190	-0.56 Neutrophils (10^9 cells/L) Standard Deviation 0.932	0.13 Neutrophils (10^9 cells/L) Standard Deviation 0.538
Change From Baseline in Neutrophils. Change from baseline in neutrophils (10^9/L) Day 28	—	0.12 Neutrophils (10^9 cells/L) Standard Deviation 0.653	-0.62 Neutrophils (10^9 cells/L) Standard Deviation 1.174	0.24 Neutrophils (10^9 cells/L) Standard Deviation 0.855

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures such as alkaline phosphatase. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline of Alkaline Phosphatase. Change from baseline in alkaline phosphatase (U/L) Day 2	2.2 Alkaline Phosphatase (U/L) Standard Deviation 7.36	—	—	—
Change From Baseline of Alkaline Phosphatase. Change from baseline in alkaline phosphatase (U/L) Day 3	—	0 Alkaline Phosphatase (U/L) Standard Deviation 0	-0.9 Alkaline Phosphatase (U/L) Standard Deviation 2.13	-0.8 Alkaline Phosphatase (U/L) Standard Deviation 2.39
Change From Baseline of Alkaline Phosphatase. Change from baseline in alkaline phosphatase (U/L) Day 4	—	-2.6 Alkaline Phosphatase (U/L) Standard Deviation 3.06	0 Alkaline Phosphatase (U/L) Standard Deviation 0	0 Alkaline Phosphatase (U/L) Standard Deviation 0
Change From Baseline of Alkaline Phosphatase. Change from baseline in alkaline phosphatase (U/L) Day 7	—	0.8 Alkaline Phosphatase (U/L) Standard Deviation 8.18	2.1 Alkaline Phosphatase (U/L) Standard Deviation 5.88	-2.8 Alkaline Phosphatase (U/L) Standard Deviation 4.61
Change From Baseline of Alkaline Phosphatase. Change from baseline in alkaline phosphatase (U/L) Day 8	1.8 Alkaline Phosphatase (U/L) Standard Deviation 7.29	—	—	—
Change From Baseline of Alkaline Phosphatase. Change from baseline in Alkaline Phosphatase (U/L) Day 14	-1.8 Alkaline Phosphatase (U/L) Standard Deviation 7.29	-0.7 Alkaline Phosphatase (U/L) Standard Deviation 9.29	1.2 Alkaline Phosphatase (U/L) Standard Deviation 7.68	-2.9 Alkaline Phosphatase (U/L) Standard Deviation 4.43
Change From Baseline of Alkaline Phosphatase. Change from baseline in alkaline phosphatase (U/L) Day 28	—	-0.8 Alkaline Phosphatase (U/L) Standard Deviation 3.79	7.0 Alkaline Phosphatase (U/L) Standard Deviation 11.37	3.7 Alkaline Phosphatase (U/L) Standard Deviation 8.9

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like alanine transaminase. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 2	-0.4 Alanine Transaminase (U/L) Standard Deviation 2.30	—	—	—
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 3	—	0 Alanine Transaminase (U/L) Standard Deviation 0	-0.9 Alanine Transaminase (U/L) Standard Deviation 2.13	-0.8 Alanine Transaminase (U/L) Standard Deviation 2.39
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 4	—	-2.6 Alanine Transaminase (U/L) Standard Deviation 3.06	0 Alanine Transaminase (U/L) Standard Deviation 0	0 Alanine Transaminase (U/L) Standard Deviation 0
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 7	—	0.8 Alanine Transaminase (U/L) Standard Deviation 8.18	2.1 Alanine Transaminase (U/L) Standard Deviation 5.88	-2.8 Alanine Transaminase (U/L) Standard Deviation 4.61
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 8	-2.0 Alanine Transaminase (U/L) Standard Deviation 2.24	—	—	—
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 14	0.2 Alanine Transaminase (U/L) Standard Deviation 2.24	-0.7 Alanine Transaminase (U/L) Standard Deviation 9.29	1.2 Alanine Transaminase (U/L) Standard Deviation 7.68	-2.9 Alanine Transaminase (U/L) Standard Deviation 4.43
Change From Baseline in Alanine Transaminase. Change from baseline in alanine transaminase (U/L) Day 28	—	-0.8 Alanine Transaminase (U/L) Standard Deviation 3.79	3.7 Alanine Transaminase (U/L) Standard Deviation 11.37	3.7 Alanine Transaminase (U/L) Standard Deviation 8.90

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like asparate aminotransferase. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 2	-1.0 Asparate aminotransferase (U/L) Standard Deviation 5.24	—	—	—
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 3	—	0 Asparate aminotransferase (U/L) Standard Deviation 0	-0.8 Asparate aminotransferase (U/L) Standard Deviation 3.26	-1.6 Asparate aminotransferase (U/L) Standard Deviation 2.5
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 4	—	-2.1 Asparate aminotransferase (U/L) Standard Deviation 1.85	0 Asparate aminotransferase (U/L) Standard Deviation 0	0 Asparate aminotransferase (U/L) Standard Deviation 0
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 7	—	0.4 Asparate aminotransferase (U/L) Standard Deviation 5.50	-2.2 Asparate aminotransferase (U/L) Standard Deviation 3.67	-2.9 Asparate aminotransferase (U/L) Standard Deviation 5.99
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 8	-1.0 Asparate aminotransferase (U/L) Standard Deviation 4.30	—	—	—
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 14	-0.4 Asparate aminotransferase (U/L) Standard Deviation 3.91	0.6 Asparate aminotransferase (U/L) Standard Deviation 6.95	-3.7 Asparate aminotransferase (U/L) Standard Deviation 5.02	-1.4 Asparate aminotransferase (U/L) Standard Deviation 4.40
Change From Baseline in Asparate Aminotransferase. Change from baseline in asparate aminotransferase (U/L) Day 28	—	1.2 Asparate aminotransferase (U/L) Standard Deviation 8.40	4.7 Asparate aminotransferase (U/L) Standard Deviation 16.73	-0.1 Asparate aminotransferase (U/L) Standard Deviation 3.96

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like urea. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 2	-0.42 Urea (U/L) Standard Deviation 0.740	—	—	—
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 3	—	0 Urea (U/L) Standard Deviation 0	-0.25 Urea (U/L) Standard Deviation 0.920	-0.71 Urea (U/L) Standard Deviation 1.746
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 4	—	-0.27 Urea (U/L) Standard Deviation 1.036	0 Urea (U/L) Standard Deviation 0	0 Urea (U/L) Standard Deviation 0
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 7	—	0.22 Urea (U/L) Standard Deviation 1.018	-0.54 Urea (U/L) Standard Deviation 1.179	-0.94 Urea (U/L) Standard Deviation 0.840
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 8	0.24 Urea (U/L) Standard Deviation 1.097	—	—	—
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 14	-0.86 Urea (U/L) Standard Deviation 1.167	-0.28 Urea (U/L) Standard Deviation 0.840	-0.38 Urea (U/L) Standard Deviation 1.232	-0.56 Urea (U/L) Standard Deviation 1.106
Change From Baseline in Urea. Change from baseline in urea (U/L) Day 28	—	0.28 Urea (U/L) Standard Deviation 1.272	-0.20 Urea (U/L) Standard Deviation 1.247	-0.80 Urea (U/L) Standard Deviation 1.103

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like creatinine. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Creatinine. Change from baseline in creatinine (umol/L) Day 2	-2.8 Creatinine (umol/L) Standard Deviation 3.03	—	—	—
Change From Baseline in Creatinine. Change from baseline in creatinine (umol/L) Day 3	—	0 Creatinine (umol/L) Standard Deviation 0	0.8 Creatinine (umol/L) Standard Deviation 4.73	1.0 Creatinine (umol/L) Standard Deviation 2.94
Change From Baseline in Creatinine. Change from baseline in creatinine (umol/L) Day 4	—	-0.5 Creatinine (umol/L) Standard Deviation 7.01	0 Creatinine (umol/L) Standard Deviation 0	0 Creatinine (umol/L) Standard Deviation 0
Change From Baseline in Creatinine. Change from baseline in creatinine (umol/L) Day 7	—	0.7 Creatinine (umol/L) Standard Deviation 6.71	-1.4 Creatinine (umol/L) Standard Deviation 6.42	-1.7 Creatinine (umol/L) Standard Deviation 3.95
Change From Baseline in Creatinine. Change from baseline in Creatinine (umol/L) Day 8	1.4 Creatinine (umol/L) Standard Deviation 3.78	—	—	—
Change From Baseline in Creatinine. Change from baseline in creatinine (umol/L) Day 14	-2.4 Creatinine (umol/L) Standard Deviation 7.54	-1.3 Creatinine (umol/L) Standard Deviation 4.55	-4.3 Creatinine (umol/L) Standard Deviation 5.81	1.6 Creatinine (umol/L) Standard Deviation 4.35
Change From Baseline in Creatinine. Change from baseline in creatinine (umol/L) Day 28	—	3.5 Creatinine (umol/L) Standard Deviation 7.37	-4.4 Creatinine (umol/L) Standard Deviation 6.46	-1.7 Creatinine (umol/L) Standard Deviation 6.63

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like gamma glutamyl transferase. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 2	-0.6 Gamma Glutamyl Transferase (U/L) Standard Deviation 3.78	—	—	—
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 3	—	0 Gamma Glutamyl Transferase (U/L) Standard Deviation 0	-1.1 Gamma Glutamyl Transferase (U/L) Standard Deviation 1.97	-0.1 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.08
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 4	—	-0.6 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.91	0 Gamma Glutamyl Transferase (U/L) Standard Deviation 0	0 Gamma Glutamyl Transferase (U/L) Standard Deviation 0
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 7	—	-0.7 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.78	-0.1 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.32	1.0 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.45
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 8	-1.0 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.55	—	—	—
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 14	0.2 Gamma Glutamyl Transferase (U/L) Standard Deviation 1.48	-0.3 Gamma Glutamyl Transferase (U/L) Standard Deviation 3.47	1.0 Gamma Glutamyl Transferase (U/L) Standard Deviation 3.67	0.4 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.59
Change From Baseline in Gamma Glutamyl Transferase. Change from baseline in gamma glutamyl transferase (U/L) Day 28	—	-1.0 Gamma Glutamyl Transferase (U/L) Standard Deviation 2.62	2.2 Gamma Glutamyl Transferase (U/L) Standard Deviation 3.80	0.6 Gamma Glutamyl Transferase (U/L) Standard Deviation 3.10

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like bilirubin. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 2	-1.0 Bilirubin (U/L) Standard Deviation 3.16	—	—	—
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 3	—	0 Bilirubin (U/L) Standard Deviation 0	1.9 Bilirubin (U/L) Standard Deviation 2.92	-0.5 Bilirubin (U/L) Standard Deviation 2.42
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 4	—	1.2 Bilirubin (U/L) Standard Deviation 1.87	0 Bilirubin (U/L) Standard Deviation 0	0 Bilirubin (U/L) Standard Deviation 0
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 7	—	0.6 Bilirubin (U/L) Standard Deviation 4.07	-1.2 Bilirubin (U/L) Standard Deviation 4.15	2.1 Bilirubin (U/L) Standard Deviation 2.88
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 8	-0.4 Bilirubin (U/L) Standard Deviation 3.51	—	—	—
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 14	-3.4 Bilirubin (U/L) Standard Deviation 3.21	-0.1 Bilirubin (U/L) Standard Deviation 3.60	-3.1 Bilirubin (U/L) Standard Deviation 2.32	-0.1 Bilirubin (U/L) Standard Deviation 3.70
Change From Baseline in Bilirubin. Change from baseline in bilirubin (U/L) Day 28	—	1.9 Bilirubin (U/L) Standard Deviation 3.60	-1.9 Bilirubin (U/L) Standard Deviation 2.80	-0.7 Bilirubin (U/L) Standard Deviation 3.83

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like lactate dehydrogenase. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in Lactate Dehydrogenase. Change from baseline in Lactate Dehydrogenase (U/L) Day 2	-0.8 Lactate Dehydrogenase (U/L) Standard Deviation 58.13	—	—	—
Change From Baseline in Lactate Dehydrogenase. Change from baseline in Lactate Dehydrogenase (U/L) Day 3	—	0 Lactate Dehydrogenase (U/L) Standard Deviation 0	-7.4 Lactate Dehydrogenase (U/L) Standard Deviation 15.04	-13.2 Lactate Dehydrogenase (U/L) Standard Deviation 14.80
Change From Baseline in Lactate Dehydrogenase. Change from baseline in Lactate Dehydrogenase (U/L) Day 4	—	-12.3 Lactate Dehydrogenase (U/L) Standard Deviation 26.24	0 Lactate Dehydrogenase (U/L) Standard Deviation 0	0 Lactate Dehydrogenase (U/L) Standard Deviation 0
Change From Baseline in Lactate Dehydrogenase. Change from baseline in Lactate Dehydrogenase (U/L) Day 7	—	-11.7 Lactate Dehydrogenase (U/L) Standard Deviation 32.39	-25.7 Lactate Dehydrogenase (U/L) Standard Deviation 20.32	-9.8 Lactate Dehydrogenase (U/L) Standard Deviation 21.44
Change From Baseline in Lactate Dehydrogenase. from baseline in Lactate Dehydrogenase (U/L) Day 8	-14.4 Lactate Dehydrogenase (U/L) Standard Deviation 53.58	—	—	—
Change From Baseline in Lactate Dehydrogenase. Change from baseline in Lactate Dehydrogenase (U/L) Day 14	-11.4 Lactate Dehydrogenase (U/L) Standard Deviation 65.22	-7.5 Lactate Dehydrogenase (U/L) Standard Deviation 43.48	-27.6 Lactate Dehydrogenase (U/L) Standard Deviation 22.39	-3.7 Lactate Dehydrogenase (U/L) Standard Deviation 23.76
Change From Baseline in Lactate Dehydrogenase. Change from baseline in Lactate Dehydrogenase (U/L) Day 28	—	-12.9 Lactate Dehydrogenase (U/L) Standard Deviation 41.15	-16.4 Lactate Dehydrogenase (U/L) Standard Deviation 23.01	-12.0 Lactate Dehydrogenase (U/L) Standard Deviation 19.20

PRIMARY outcome

Timeframe: For Part A on Days 2, 8 and 14 and For Part B on Days 3 or 4, 7, 14 and 28

Clinical laboratory safety data will be summarized by laboratory measures like prothrombin intl. normalized ratio. 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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio Day 2	-0.06 Prothrombin Intl. Normalized Ratio Standard Deviation 0.055	—	—	—
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio Day 3	—	0 Prothrombin Intl. Normalized Ratio Standard Deviation 0	0.01 Prothrombin Intl. Normalized Ratio Standard Deviation 0.057	-0.03 Prothrombin Intl. Normalized Ratio Standard Deviation 0.048
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio Day 4	—	0.01 Prothrombin Intl. Normalized Ratio Standard Deviation 0.032	0 Prothrombin Intl. Normalized Ratio Standard Deviation 0	0 Prothrombin Intl. Normalized Ratio Standard Deviation 0
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio day 7	—	0.02 Prothrombin Intl. Normalized Ratio Standard Deviation 0.067	0.01 Prothrombin Intl. Normalized Ratio Standard Deviation 0.033	0.00 Prothrombin Intl. Normalized Ratio Standard Deviation 0.047
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio Day 8	-0.02 Prothrombin Intl. Normalized Ratio Standard Deviation 0.045	—	—	—
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio day 14	-0.06 Prothrombin Intl. Normalized Ratio Standard Deviation 0.055	-0.01 Prothrombin Intl. Normalized Ratio Standard Deviation 0.057	0.00 Prothrombin Intl. Normalized Ratio Standard Deviation 0.050	-0.02 Prothrombin Intl. Normalized Ratio Standard Deviation 0.042
Change From Baseline of Prothrombin Intl. Normalized Ratio. Change from baseline in prothrombin intl. normalized ratio Day 28	—	0.00 Prothrombin Intl. Normalized Ratio Standard Deviation 0.047	0.02 Prothrombin Intl. Normalized Ratio Standard Deviation 0.044	0 Prothrombin Intl. Normalized Ratio Standard Deviation 0

PRIMARY outcome

Timeframe: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.

The following ECG parameters will be analyzed: single RR heart rate (beats/min). Observed values and changes from baseline for single RR heart rate (beats/min). will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Single RR Heart Rate (Beats/Min). Change from baseline in single RR heart rate (beats/min) Day 14	5.00 Single RR heart rate (beats/min) Standard Deviation 3.940	—	—	—
Changes From Baseline of Single RR Heart Rate (Beats/Min). Change from baseline in single RR heart rate (beats/min) Day 28	—	3.08 Single RR heart rate (beats/min) Standard Deviation 8.160	0.54 Single RR heart rate (beats/min) Standard Deviation 6.610	2.29 Single RR heart rate (beats/min) Standard Deviation 7.010

PRIMARY outcome

Timeframe: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.

The following ECG parameters will be analyzed: QRS duration, single beat (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of QRS Duration, Single Beat (ms). Change from baseline in QRS duration (ms) Day 14	2.06 QRS duration, single beat (ms) Standard Deviation 4.210	—	—	—
Changes From Baseline of QRS Duration, Single Beat (ms). Change from baseline in QRS duration (ms) Day 28	—	2.24 QRS duration, single beat (ms) Standard Deviation 2.780	0.38 QRS duration, single beat (ms) Standard Deviation 5.770	-1.95 QRS duration, single beat (ms) Standard Deviation 5.170

PRIMARY outcome

Timeframe: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.

The following ECG parameters will be analyzed: PR interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in PR Interval, Single Beat (ms). Change from baseline in PR Interval, single beat (ms) Day 14	-4.94 PR Interval, single beat (ms) Standard Deviation 12.880	—	—	—
Change From Baseline in PR Interval, Single Beat (ms). Change from baseline in PR Interval, single beat (ms) Day 28	—	-0.51 PR Interval, single beat (ms) Standard Deviation 6.870	1.06 PR Interval, single beat (ms) Standard Deviation 3.960	-1.53 PR Interval, single beat (ms) Standard Deviation 11.380

PRIMARY outcome

Timeframe: Change from baseline to Day 14 for the Sentinel Cohort (Part A), and change from baseline to Day 28 for the Main Cohort (Part B).

Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.

The following ECG parameters will be analyzed: QTcB Interval. Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in QTcB Interval, Single-beat (ms) Change from baseline in QTcB Interval, Single-beat (ms) Day 14	0.78 QTcB Interval, Single-beat (ms) Standard Deviation 21.290	—	—	—
Change From Baseline in QTcB Interval, Single-beat (ms) Change from baseline in QTcB Interval, Single-beat (ms) Day 28	—	4.08 QTcB Interval, Single-beat (ms) Standard Deviation 13.040	-2.38 QTcB Interval, Single-beat (ms) Standard Deviation 13.380	-1.44 QTcB Interval, Single-beat (ms) Standard Deviation 15.580

PRIMARY outcome

Timeframe: Change from baseline to end of study.

Population: The Sentinel Cohort (Part A) had their end of study visit at Day 14, while the Main Cohort (Part B) had their end of study visit at Day 28.

The following ECG parameters will be analyzed: QTcF Interval (ms). Observed values and changes from baseline for ECG parameters will be summarized at each scheduled timepoint using descriptive statistics. For QTcF Interval, 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 International Conference of Harmonization (ICH) E14

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Change From Baseline in QTcF Interval (ms). Change from baseline in QTcF Interval (ms) Day 14	-4.54 QTcF Interval (ms) Standard Deviation 17.810	—	—	—
Change From Baseline in QTcF Interval (ms). Change from baseline in QTcF Interval (ms) Day 28	—	0.92 QTcF Interval (ms) Standard Deviation 8.730	-2.91 QTcF Interval (ms) Standard Deviation 14.320	-3.47 QTcF Interval (ms) Standard Deviation 11.680

PRIMARY outcome

Timeframe: For Part A Days 1 and 8. For Part B Days 1, 7, 14 and 28

The sino-nasal outcome test (SNOT-22) is to measure the consequences of rhinosinusitis. Scores will be totaled for all 22 items. The minimum score on the sinonasal outcome test-22 (SNOT-22) is 0 and the maximum score is 110. Changes from baseline in individual total sinonasal outcome test-22 (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.

Outcome measures

Outcome measures
Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) Change from baseline in SNOT-22 scores - Day 1	2.6 Sinonasal outcome test-22 scores Standard Deviation 4.83	1.9 Sinonasal outcome test-22 scores Standard Deviation 1.79	1.4 Sinonasal outcome test-22 scores Standard Deviation 2.17	1.1 Sinonasal outcome test-22 scores Standard Deviation 1.20
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) Change from baseline in SNOT-22 scores - Day 7	—	-1.0 Sinonasal outcome test-22 scores Standard Deviation 3.12	-2.1 Sinonasal outcome test-22 scores Standard Deviation 4.29	3.4 Sinonasal outcome test-22 scores Standard Deviation 6.80
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) Change from baseline in SNOT-22 scores - Day 8	2.4 Sinonasal outcome test-22 scores Standard Deviation 3.36	—	—	—
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) Change from baseline in SNOT-22 scores - Day 14	—	3.0 Sinonasal outcome test-22 scores Standard Deviation 10.54	-3.0 Sinonasal outcome test-22 scores Standard Deviation 3.82	3.3 Sinonasal outcome test-22 scores Standard Deviation 7.47
Changes From Baseline Nasal Symptoms Using the Sino-Nasal Outcome Test (Total Score) Change from baseline in SNOT-22 scores - Day 28	—	0.7 Sinonasal outcome test-22 scores Standard Deviation 7.82	-3.6 Sinonasal outcome test-22 scores Standard Deviation 3.93	-0.5 Sinonasal outcome test-22 scores Standard Deviation 2.32

Adverse Events

Sentinel Cohort

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Main Cohort Group 1

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Main Cohort Group 2

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Main Cohort Group 3

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Sentinel Cohort n=5 participants at risk Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 participants at risk Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=10 participants at risk Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 participants at risk Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Respiratory, thoracic and mediastinal disorders Viral upper respiratory	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Respiratory, thoracic and mediastinal disorders Rhinorrhea	100.0% 5/5 • Number of events 12 • 28 days	60.0% 6/10 • Number of events 7 • 28 days	30.0% 3/10 • Number of events 3 • 28 days	50.0% 5/10 • Number of events 5 • 28 days
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Infections and infestations Influenza	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Respiratory, thoracic and mediastinal disorders Throat irritation	20.0% 1/5 • Number of events 1 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	20.0% 2/10 • Number of events 2 • 28 days
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/5 • 28 days	40.0% 4/10 • Number of events 4 • 28 days	40.0% 4/10 • Number of events 4 • 28 days	30.0% 3/10 • Number of events 3 • 28 days
Nervous system disorders Ansomnia	0.00% 0/5 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	0.00% 0/10 • 28 days
Respiratory, thoracic and mediastinal disorders Hyposmia	0.00% 0/5 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Respiratory, thoracic and mediastinal disorders Nasal discomfort	0.00% 0/5 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Respiratory, thoracic and mediastinal disorders Rhinalgia	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Nervous system disorders Headache	60.0% 3/5 • Number of events 8 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	20.0% 2/10 • Number of events 2 • 28 days
Respiratory, thoracic and mediastinal disorders Epistaxis	40.0% 2/5 • Number of events 3 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	20.0% 2/10 • Number of events 2 • 28 days
Gastrointestinal disorders Nasuea	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Blood and lymphatic system disorders Neutropenia	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Investigations Neotrophil count decreased	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Gastrointestinal disorders Vomiting	20.0% 1/5 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
General disorders Fatigue	0.00% 0/5 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	30.0% 3/10 • Number of events 3 • 28 days
Nervous system disorders Ageusia	0.00% 0/5 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Nervous system disorders Dizziness	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	20.0% 2/10 • Number of events 2 • 28 days	0.00% 0/10 • 28 days
Respiratory, thoracic and mediastinal disorders Nasal mucosal disorder	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	20.0% 2/10 • Number of events 2 • 28 days
Respiratory, thoracic and mediastinal disorders Rhinitis atrophic	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/5 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Nervous system disorders Hypogeusia	0.00% 0/5 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Eye disorders Dry eye	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days
General disorders Exercise tolerance decreased	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
General disorders Feeling hot	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Gastrointestinal disorders Food poisoning	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
Respiratory, thoracic and mediastinal disorders Nasal pruritus	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
General disorders Pain	0.00% 0/5 • 28 days	10.0% 1/10 • Number of events 1 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days
Musculoskeletal and connective tissue disorders Temporomandibular joint syndrome	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days
General disorders Thirst	0.00% 0/5 • 28 days	0.00% 0/10 • 28 days	0.00% 0/10 • 28 days	10.0% 1/10 • Number of events 1 • 28 days

Additional Information

Senior Medical Director

Lumen Bioscience

Phone: 206-899-1904

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Sentinel Cohort n=5 Participants Part A: single fixed dose of 50 mg LMN-301 IN (25 mg in each nostril)	Main Cohort Group 1 n=10 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) LMN-301 once every third day for 12 days (4 doses total)	Main Cohort Group 2 n=9 Participants Cohort 2, Part B: 50 mg (25 mg in each nostril) once every other day for 12 days (6 doses total)	Main Cohort Group 3 n=10 Participants Cohort 2, Part B: Part B: 50 mg (25 mg in each nostril) once every day for 12 days (12 doses total)
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose	—	1.4 Delta from baseline blood pressure(mmHg) Standard Deviation 11.21	-1.3 Delta from baseline blood pressure(mmHg) Standard Deviation 8.22	-2.4 Delta from baseline blood pressure(mmHg) Standard Deviation 4.50
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose	0.4 Delta from baseline blood pressure(mmHg) Standard Deviation 8.08	-1.7 Delta from baseline blood pressure(mmHg) Standard Deviation 10.13	-2.8 Delta from baseline blood pressure(mmHg) Standard Deviation 7.02	-2.5 Delta from baseline blood pressure(mmHg) Standard Deviation 10.81
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 1, 1 hour post-dose	-1.8 Delta from baseline blood pressure(mmHg) Standard Deviation 8.58	-1.9 Delta from baseline blood pressure(mmHg) Standard Deviation 9.88	-2.2 Delta from baseline blood pressure(mmHg) Standard Deviation 5.39	-0.9 Delta from baseline blood pressure(mmHg) Standard Deviation 5.11
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 1, 4 hours post-dose	5.2 Delta from baseline blood pressure(mmHg) Standard Deviation 6.61	4.7 Delta from baseline blood pressure(mmHg) Standard Deviation 8.53	-1.1 Delta from baseline blood pressure(mmHg) Standard Deviation 6.33	1.2 Delta from baseline blood pressure(mmHg) Standard Deviation 7.07
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 2	-0.6 Delta from baseline blood pressure(mmHg) Standard Deviation 8.32	—	—	—
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 3	—	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	-4.3 Delta from baseline blood pressure(mmHg) Standard Deviation 6.33	-1.5 Delta from baseline blood pressure(mmHg) Standard Deviation 9.00
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 4	—	-1.6 Delta from baseline blood pressure(mmHg) Standard Deviation 10.56	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic from baseline in blood pressure (mmHg) - Day 7	—	2.9 Delta from baseline blood pressure(mmHg) Standard Deviation 14.13	-3.8 Delta from baseline blood pressure(mmHg) Standard Deviation 8.51	-4.1 Delta from baseline blood pressure(mmHg) Standard Deviation 7.00
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic change from baseline in blood pressure (mmHg) - Day 8	0.4 Delta from baseline blood pressure(mmHg) Standard Deviation 15.92	—	—	—
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 10	—	1.3 Delta from baseline blood pressure(mmHg) Standard Deviation 11.68	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 11	—	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	-6.6 Delta from baseline blood pressure(mmHg) Standard Deviation 8.65	-2.9 Delta from baseline blood pressure(mmHg) Standard Deviation 6.92
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 14	1.2 Delta from baseline blood pressure(mmHg) Standard Deviation 7.79	3.4 Delta from baseline blood pressure(mmHg) Standard Deviation 15.06	-4.0 Delta from baseline blood pressure(mmHg) Standard Deviation 9.23	-1.5 Delta from baseline blood pressure(mmHg) Standard Deviation 8.96
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in systolic blood pressure (mmHg) - Day 28	—	1.6 Delta from baseline blood pressure(mmHg) Standard Deviation 14.80	-3.1 Delta from baseline blood pressure(mmHg) Standard Deviation 7.56	2.2 Delta from baseline blood pressure(mmHg) Standard Deviation 8.57
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.25 hour post-dose	—	0.2 Delta from baseline blood pressure(mmHg) Standard Deviation 6.11	-0.6 Delta from baseline blood pressure(mmHg) Standard Deviation 3.91	0.3 Delta from baseline blood pressure(mmHg) Standard Deviation 6.60
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 1, 0.5 hour post-dose	2.2 Delta from baseline blood pressure(mmHg) Standard Deviation 4.76	-2.7 Delta from baseline blood pressure(mmHg) Standard Deviation 5.87	-2.0 Delta from baseline blood pressure(mmHg) Standard Deviation 4.78	-1.8 Delta from baseline blood pressure(mmHg) Standard Deviation 6.37
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 1, 1 hour post-dose	1.0 Delta from baseline blood pressure(mmHg) Standard Deviation 7.21	-1.9 Delta from baseline blood pressure(mmHg) Standard Deviation 5.09	-1.8 Delta from baseline blood pressure(mmHg) Standard Deviation 5.18	0.9 Delta from baseline blood pressure(mmHg) Standard Deviation 6.26
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure - Day 1, 4 hours post-dose	1.0 Delta from baseline blood pressure(mmHg) Standard Deviation 10.32	-2.1 Delta from baseline blood pressure(mmHg) Standard Deviation 5.99	-2.5 Delta from baseline blood pressure(mmHg) Standard Deviation 5.66	-0.4 Delta from baseline blood pressure(mmHg) Standard Deviation 7.88
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 2 post-dose	0.0 Delta from baseline blood pressure(mmHg) Standard Deviation 4.18	—	—	—
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 3	—	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	-3.4 Delta from baseline blood pressure(mmHg) Standard Deviation 7.47	-1.9 Delta from baseline blood pressure(mmHg) Standard Deviation 6.56
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 4	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	0.1 Delta from baseline blood pressure(mmHg) Standard Deviation 7.31	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 7	—	-0.3 Delta from baseline blood pressure(mmHg) Standard Deviation 7.09	-3.9 Delta from baseline blood pressure(mmHg) Standard Deviation 8.88	-1.1 Delta from baseline blood pressure(mmHg) Standard Deviation 4.72
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 8	-1.6 Delta from baseline blood pressure(mmHg) Standard Deviation 4.39	—	—	—
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 10	—	0.9 Delta from baseline blood pressure(mmHg) Standard Deviation 8.51	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 11	—	0 Delta from baseline blood pressure(mmHg) Standard Deviation 0	-6.0 Delta from baseline blood pressure(mmHg) Standard Deviation 7.40	-0.7 Delta from baseline blood pressure(mmHg) Standard Deviation 6.99
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 14	1.6 Delta from baseline blood pressure(mmHg) Standard Deviation 5.77	1.4 Delta from baseline blood pressure(mmHg) Standard Deviation 9.79	-2.2 Delta from baseline blood pressure(mmHg) Standard Deviation 5.70	0.7 Delta from baseline blood pressure(mmHg) Standard Deviation 6.63
Changes From Baseline of Systolic and Diastolic Blood Pressure. Change from baseline in diastolic blood pressure (mmHg) - Day 28	—	0.0 Delta from baseline blood pressure(mmHg) Standard Deviation 8.33	-3.1 Delta from baseline blood pressure(mmHg) Standard Deviation 7.25	4.1 Delta from baseline blood pressure(mmHg) Standard Deviation 6.19