Trial Outcomes & Findings for A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16 (NCT NCT03338556)

Last Updated: 2018-11-09

Results Overview

Overall total symptom score (TSS), defined as the sum of the total symptom scores from day 1 to day 8 inclusive, using the 10-point symptom diary card on a 0 - 3 point scale The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities: Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache. Diary cards were filled out 3 times/day on Day 1-7 and once on Day 8. Possible range of outcomes for TSS: 0 - 660 (higher numbers indicating worse outcomes)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

8 days

Results posted on

2018-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A - PrEP-001 PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort A - Placebo Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Cohort B- PrEP-001 PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort B - Placebo Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo
Overall Study STARTED	25	27	24	26
Overall Study COMPLETED	23	23	22	24
Overall Study NOT COMPLETED	2	4	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Examine the Duration of Effect of PrEP-001 in Healthy Subjects Challenged With HRV-16

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A - PrEP-001 n=25 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort A - Placebo n=27 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Cohort B- PrEP-001 n=24 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort B - Placebo n=26 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Total n=102 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=93 Participants	27 Participants n=4 Participants	24 Participants n=27 Participants	26 Participants n=483 Participants	102 Participants n=36 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants	0 Participants n=36 Participants
Age, Continuous	24.3 years STANDARD_DEVIATION 6.26 • n=93 Participants	24.9 years STANDARD_DEVIATION 8.30 • n=4 Participants	21.7 years STANDARD_DEVIATION 2.93 • n=27 Participants	22.2 years STANDARD_DEVIATION 3.58 • n=483 Participants	23.3 years STANDARD_DEVIATION 5.84 • n=36 Participants
Sex: Female, Male Female	12 Participants n=93 Participants	11 Participants n=4 Participants	4 Participants n=27 Participants	9 Participants n=483 Participants	36 Participants n=36 Participants
Sex: Female, Male Male	13 Participants n=93 Participants	16 Participants n=4 Participants	20 Participants n=27 Participants	17 Participants n=483 Participants	66 Participants n=36 Participants
Region of Enrollment United Kingdom	25 participants n=93 Participants	27 participants n=4 Participants	24 participants n=27 Participants	26 participants n=483 Participants	102 participants n=36 Participants

PRIMARY outcome

Timeframe: 8 days

Population: ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)

Outcome measures

Outcome measures
Measure	Cohort A - PrEP-001 n=23 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort A - Placebo n=23 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Cohort B- PrEP-001 n=21 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort B - Placebo n=24 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo
Total Symptom Scores	22.5 units on a scale Standard Deviation 21.63	34.2 units on a scale Standard Deviation 38.67	36.2 units on a scale Standard Deviation 38.19	33.5 units on a scale Standard Deviation 40.54

SECONDARY outcome

Timeframe: 8 days

Population: ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)

Total symptom scores (from the 10-item modified Jackson symptom diary card) were used to calculate the AUC, from Day 1 (Assessment 1) to Day 8, after challenge, for each subject using the trapezium rule, based on the available non-missing calculated total symptom scores between Day 1 (Assessment 1) and Day 8. The 10-point symptom diary card, measured three times daily was combined to generate total symptom score. The following symptoms in the 10-item symptoms questionnaire were graded on a scale of 0-3, where Grade 0 was absence, Grade 1 was just noticeable, Grade 2 was bothersome but did not prevent participation in activities, and Grade 3 was bothersome and interfered with activities: Runny nose, Stuffy nose, Sneezing, Sore throat, Earache, Tiredness, Cough, Shortness of breath, Headache, Muscle/joint ache

Outcome measures

Outcome measures
Measure	Cohort A - PrEP-001 n=23 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort A - Placebo n=23 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Cohort B- PrEP-001 n=20 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort B - Placebo n=23 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo
Area Under Curve of Symptom Scores	10668.8 scores*minutes Standard Deviation 10359.03	16543.3 scores*minutes Standard Deviation 18742.21	17782.2 scores*minutes Standard Deviation 18533.03	16385.7 scores*minutes Standard Deviation 19936.53

SECONDARY outcome

Timeframe: 8 days

Population: ITT analysis. Note :Cohort B PrEP-001 active group had n=21 (one less than completed the study n=22)

The number of subjects with laboratory confirmed HRV-16 infection (as defined by a positive quantitative polymerase chain reaction (qPCR) result from the combined nasal washes of days 3, 4 and 5) who displayed clinical symptoms of upper respiratory tract (using the 10-item diary card, Day 1 to Day 8) - ITT analysis set

Outcome measures

Outcome measures
Measure	Cohort A - PrEP-001 n=23 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort A - Placebo n=23 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Cohort B- PrEP-001 n=21 Participants PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort B - Placebo n=24 Participants Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo
Incidence(s) of Laboratory Confirmed Illness	10 participants	13 participants	13 participants	12 participants

Adverse Events

Cohort A - PrEP-001

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Cohort A - Placebo

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Cohort B- PrEP-001

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Cohort B - Placebo

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort A - PrEP-001 n=25 participants at risk PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort A - Placebo n=27 participants at risk Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 7 and Day - 6 prior to intranasal challenge with HRV-16 (Day 0). Placebo	Cohort B- PrEP-001 n=24 participants at risk PrEP-001 6400 μg/day, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). PrEP-001	Cohort B - Placebo n=26 participants at risk Placebo matching PrEP-001, equally divided over both nostrils, on 2 consecutive days. Dosed Day - 4 and Day - 3 prior to intranasal challenge with HRV-16 (Day 0). Placebo
Injury, poisoning and procedural complications Procedural haemorrhage	48.0% 12/25	33.3% 9/27	33.3% 8/24	23.1% 6/26
Injury, poisoning and procedural complications Sunburn	0.00% 0/25	3.7% 1/27	4.2% 1/24	0.00% 0/26
Investigations C-reactive protein increased	0.00% 0/25	7.4% 2/27	8.3% 2/24	15.4% 4/26
Investigations Blood fibrinogen increased	12.0% 3/25	7.4% 2/27	0.00% 0/24	0.00% 0/26
Investigations Alanine aminotransferase increased	0.00% 0/25	0.00% 0/27	12.5% 3/24	3.8% 1/26
Investigations Aspartate aminotransferase increased	0.00% 0/25	3.7% 1/27	8.3% 2/24	0.00% 0/26
Investigations Blood bilirubin increased	4.0% 1/25	0.00% 0/27	4.2% 1/24	3.8% 1/26
Investigations Lymphocyte count decreased	0.00% 0/25	7.4% 2/27	0.00% 0/24	0.00% 0/26
Investigations Neutrophil count decreased	4.0% 1/25	0.00% 0/27	4.2% 1/24	0.00% 0/26
Respiratory, thoracic and mediastinal disorders Epistaxis	12.0% 3/25	0.00% 0/27	0.00% 0/24	0.00% 0/26
Respiratory, thoracic and mediastinal disorders Blood and lymphatic system disorders	0.00% 0/25	3.7% 1/27	8.3% 2/24	3.8% 1/26
Respiratory, thoracic and mediastinal disorders Neutropenia	0.00% 0/25	0.00% 0/27	4.2% 1/24	3.8% 1/26
Respiratory, thoracic and mediastinal disorders Nervous system disorders	0.00% 0/25	0.00% 0/27	8.3% 2/24	0.00% 0/26
Respiratory, thoracic and mediastinal disorders Headache	0.00% 0/25	0.00% 0/27	8.3% 2/24	0.00% 0/26

Additional Information

Chief Medical Officer

PrEP Biopharm Limited

Phone: 8666207176

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place