Trial Outcomes & Findings for Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model (NCT NCT05507567)
NCT ID: NCT05507567
Last Updated: 2024-10-28
Results Overview
Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point. Viral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Day 1 to Day 8
Results posted on
2024-10-28
Participant Flow
Following screening (Day -93 to Day -5), this study was conducted with an inpatient phase (Day -4 to Day 8) and an outpatient follow-up on Day 28 (plus or minus 3 days). During the inpatient quarantine phase, participants received Neumifil or placebo according to the randomisation on Day -3, Day -2 and Day -1, and then received Influenza Challenge Virus on Day 0. The study was conducted at one site in the UK between 12 August 2022 and 03 May 2023.
Participant milestones
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
Neumifil: Liquid for intranasal spray administration
|
Neumifil Single Dose Prophylactic Treatment
Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge
Neumifil: Liquid for intranasal spray administration
Placebo: Liquid for intranasal spray administration
|
Placebo
Intranasal spray administered as 3 single daily doses prior to viral challenge
Placebo: Liquid for intranasal spray administration
|
|---|---|---|---|
|
Randomised and Received Challenge Virus
STARTED
|
32
|
31
|
41
|
|
Randomised and Received Challenge Virus
COMPLETED
|
30
|
31
|
40
|
|
Randomised and Received Challenge Virus
NOT COMPLETED
|
2
|
0
|
1
|
|
From Challenge Virus to End of Study
STARTED
|
30
|
31
|
40
|
|
From Challenge Virus to End of Study
COMPLETED
|
30
|
29
|
40
|
|
From Challenge Virus to End of Study
NOT COMPLETED
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
Neumifil: Liquid for intranasal spray administration
|
Neumifil Single Dose Prophylactic Treatment
Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge
Neumifil: Liquid for intranasal spray administration
Placebo: Liquid for intranasal spray administration
|
Placebo
Intranasal spray administered as 3 single daily doses prior to viral challenge
Placebo: Liquid for intranasal spray administration
|
|---|---|---|---|
|
Randomised and Received Challenge Virus
Lost to Follow-up
|
0
|
0
|
1
|
|
Randomised and Received Challenge Virus
Physician Decision
|
1
|
0
|
0
|
|
Randomised and Received Challenge Virus
Did not complete quarantine
|
1
|
0
|
0
|
|
From Challenge Virus to End of Study
Withdrawal by Subject
|
0
|
2
|
0
|
Baseline Characteristics
Safety, Tolerability and Prophylactic Antiviral Activity of Neumifil Against Influenza Via a Human Viral Challenge Model
Baseline characteristics by cohort
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=32 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
Neumifil: Liquid for intranasal spray administration
|
Neumifil Single Dose Prophylactic Treatment
n=31 Participants
Neumifil intranasal spray administered as a single dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge
Neumifil: Liquid for intranasal spray administration
Placebo: Liquid for intranasal spray administration
|
Placebo
n=41 Participants
Intranasal spray administered as 3 single daily doses prior to viral challenge
Placebo: Liquid for intranasal spray administration
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
31.22 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
30.32 years
STANDARD_DEVIATION 7.06 • n=7 Participants
|
31.05 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
30.88 years
STANDARD_DEVIATION 7.67 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
72 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
99 Participants
n=4 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
32 participants
n=5 Participants
|
31 participants
n=7 Participants
|
41 participants
n=5 Participants
|
104 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: Per Protocol population (participants who received all doses, challenge virus and completed quarantine up to Day 8)
Number of subjects with quantifiable viral shedding on 2 consecutive days AND with any symptom score of grade 2 or greater at a single time point. Viral shedding was measured by RT-qPCR. Eleven symptoms were assessed by questionnaire and were graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=30 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=29 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=40 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=59 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Incidence of Symptomatic Influenza Infection
|
6 Participants
|
6 Participants
|
16 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: Day 1 to Day 8Population: Per Protocol population
Change in Peak Total Symptom Score (TSS) as measured by graded symptom scoring system collected 3 times daily; symptom questionnaire was graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. The range was 0 to 33.
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=30 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=29 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=40 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=59 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Severity of Symptoms
|
3.00 Scores on a scale
Interval 0.0 to 16.0
|
1.00 Scores on a scale
Interval 0.0 to 12.0
|
3.00 Scores on a scale
Interval 0.0 to 17.0
|
2.00 Scores on a scale
Interval 0.0 to 16.0
|
SECONDARY outcome
Timeframe: Day 1 to Day 8Population: Per Protocol population
Participants completed a self-assessment symptom score 3 times daily, graded on a scale of 0-3 (grade 0: no symptoms; grade 1: just noticeable; grade 2: clearly bothersome from time to time but does not interfere with me doing my normal daily activities; grade 3: quite bothersome most or all of the time, and it stops me participating in activities).Lower score means better outcome. Range 0 to 33
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=30 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=29 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=40 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=59 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) Over Time of Total Symptom Score (TSS)
|
4.05 (Units on a scale)*day
Interval 0.0 to 47.7
|
0.11 (Units on a scale)*day
Interval 0.0 to 25.8
|
3.73 (Units on a scale)*day
Interval 0.0 to 50.0
|
2.44 (Units on a scale)*day
Interval 0.0 to 47.7
|
SECONDARY outcome
Timeframe: Day 1 (pm) to Day 8 (am)Population: Per Protocol Population
Measurement of influenza viral load (VL) area under the curve (VL-AUC) of quantifiable measurements by RT-qPCR in nasal samples. The AUC is expressed as the log to the base 10 copies in a mL of nasal fluid multiplied by the time in days \[(log10 copies/mL)\*day\]. The higher the viral load AUC, by PCR, the worse the outcome.
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=30 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=29 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=40 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=59 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Viral Shedding Over Time
|
9.96 (log10 copies/mL)*day
Interval 6.3 to 40.2
|
8.60 (log10 copies/mL)*day
Interval 6.3 to 39.0
|
17.24 (log10 copies/mL)*day
Interval 6.3 to 44.8
|
9.39 (log10 copies/mL)*day
Interval 6.3 to 40.2
|
SECONDARY outcome
Timeframe: Day 1 (pm) to Day 8 (am)Population: Per Protocol population (one participant in the placebo group had a missing value)
Measurement of influenza viral load (VL) in nasal samples over time (VL-AUC) measured by viral culture. Nasal secretions were cultured and the Tissue Culture Infectious Dose (TCID50) calculated. The AUC of log to the base 10 of the TCID50 in each mL of nasal secretions, multiplied by the time in days \[(log10 TCID50/mL)\*day\] was calculated. The higher the viral load AUC by culture, the worse the outcome.
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=30 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=29 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=39 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=59 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Viral Shedding Over Time
|
3.29 (log10 TCID50/mL)*day
Interval 3.2 to 15.7
|
3.30 (log10 TCID50/mL)*day
Interval 3.2 to 18.0
|
4.79 (log10 TCID50/mL)*day
Interval 3.2 to 17.9
|
3.30 (log10 TCID50/mL)*day
Interval 3.2 to 18.0
|
SECONDARY outcome
Timeframe: Day 1 (am) to Day 8 (am)Population: Per Protocol population (Data not available for all participants)
Measurement of total weight of mucus produced by participants. The total weight of used tissues was measured to assess the weight of mucus produced. The greater the weight of the tissues the more mucus produced and the worse the outcome.
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=23 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=24 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=35 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=47 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Weight of Nasal Discharge
|
5.24 grams
Interval 0.0 to 83.2
|
0.26 grams
Interval 0.0 to 54.2
|
2.74 grams
Interval 0.0 to 43.7
|
0.97 grams
Interval 0.0 to 83.2
|
SECONDARY outcome
Timeframe: Day 1 (am) to Day 8 (am)Population: Per Protocol population (Data not available for all participants)
The number of tissues used by participants were counted. The greater the number of tissues used the worse the outcome.
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=25 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=25 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=35 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
n=50 Participants
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Nasal Discharge
|
14.00 sum of number of tissues
Interval 0.0 to 144.0
|
2.00 sum of number of tissues
Interval 0.0 to 88.0
|
7.00 sum of number of tissues
Interval 0.0 to 52.0
|
5.5 sum of number of tissues
Interval 0.0 to 144.0
|
SECONDARY outcome
Timeframe: From intake of first dose of IMP (Day -3) up to 12 hours post the last IMP dose (Day -1)Population: Safety population
Number of participants reporting a solicited adverse event during the treatment period of IMP
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=32 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=31 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=41 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Adverse Events, Solicited
|
29 Participants
|
22 Participants
|
29 Participants
|
—
|
SECONDARY outcome
Timeframe: From intake of first dose of IMP on Day -3 to Day 28Population: Safety population
Number of participants reporting treatment emergent adverse events, unsolicited
Outcome measures
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=32 Participants
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
|
Neumifil Single Dose Prophylactic Treatment
n=31 Participants
Neumifil intranasal spray administered as a single daily dose on Day -3 prior to viral challenge
|
Placebo
n=41 Participants
Placebo intranasal spray administered as 3 single daily doses prior to viral challenge
|
Pooled Neumifil Groups
Pooled groups:Neumifil intranasal spray administered prior to viral challenge
|
|---|---|---|---|---|
|
Adverse Events, Unsolicited
|
9 Participants
|
8 Participants
|
17 Participants
|
—
|
Adverse Events
Neumifil Multiple Dose Prophylactic Treatment
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Neumifil Single Dose Prophylactic Treatment
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neumifil Multiple Dose Prophylactic Treatment
n=32 participants at risk
Neumifil intranasal spray administered as 3 single daily doses prior to viral challenge
Neumifil: Liquid for intranasal spray administration
|
Neumifil Single Dose Prophylactic Treatment
n=31 participants at risk
Neumifil intranasal spray administered as a single daily dose on Day -3 and blinded by placebo administered as two single daily doses. All administrations completed prior to viral challenge
Neumifil: Liquid for intranasal spray administration
Placebo: Liquid for intranasal spray administration
|
Placebo
n=41 participants at risk
Intranasal spray administered as 3 single daily doses prior to viral challenge
Placebo: Liquid for intranasal spray administration
|
|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
General disorders
Peripheral swelling
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Eye disorders
Asthenopia
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
2/32 • Number of events 2 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
9.7%
3/31 • Number of events 3 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
7.3%
3/41 • Number of events 3 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Infections and infestations
Covid-19
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Infections and infestations
Tonsilitis
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Aspartate aminotransferase increased
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
C-reactive protein increased
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Electrocardiogram T wave abnormal
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Electrocardiogram T wave biphasic
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Forced expiratory volume decreased
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Investigations
Hepatic enzyme abnormal
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
4.9%
2/41 • Number of events 2 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
General disorders
Axillary pain
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Eye disorders
Blepharitis
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Nervous system disorders
Anosmia
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Nervous system disorders
Headache
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/31 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
0.00%
0/41 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Bleeding from the nose
|
3.1%
1/32 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
9.7%
3/31 • Number of events 3 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
4.9%
2/41 • Number of events 6 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Burning sensation or sensation of heat/hotness in the nose
|
18.8%
6/32 • Number of events 7 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
9.7%
3/31 • Number of events 7 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
12.2%
5/41 • Number of events 8 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
General irritation in the nose
|
50.0%
16/32 • Number of events 40 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
38.7%
12/31 • Number of events 26 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
39.0%
16/41 • Number of events 32 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Nervous system disorders
Marked change in sense of smell or taste
|
9.4%
3/32 • Number of events 6 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
3.2%
1/31 • Number of events 1 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
2.4%
1/41 • Number of events 2 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Pain or stinging in the nose
|
21.9%
7/32 • Number of events 9 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
25.8%
8/31 • Number of events 11 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
14.6%
6/41 • Number of events 10 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Sensation of needing to blow your nose
|
68.8%
22/32 • Number of events 70 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
45.2%
14/31 • Number of events 30 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
29.3%
12/41 • Number of events 28 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
56.2%
18/32 • Number of events 40 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
35.5%
11/31 • Number of events 18 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
36.6%
15/41 • Number of events 30 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
|
Gastrointestinal disorders
Unpleasant taste
|
37.5%
12/32 • Number of events 27 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
25.8%
8/31 • Number of events 10 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
31.7%
13/41 • Number of events 22 • From the intake of the first dose of IMP on Day -3 to Day 28
Unsolicited Treatment Emergent Adverse Events were collected by open and non-leading verbal questioning from Day -3 to Day 28. Solicited adverse events were collected using participant completed questionnaires 1 hour and 12 hours after each dose of study medication from Day -3 to Day -1.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place