Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19

• Sponsor: MedinCell S.A (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04632706
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Arms: 4
• Actual Duration (Months): 5.5
• Patients Per Site Per Month: 4.3

Study Details

Study Description

Brief Summary

An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Ivermectin; Drug: Placebo	Phase 1

Detailed Description

Detailed information restricted because this is a Phase 1 clinical trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: The study is a placebo-controlled, double-blinded exploratory study to investigate safety, Pk and tolerability of a continuous daily dosing of the active drugs (at 3 different doses) in healthy participants.The study is a placebo-controlled, double-blinded exploratory study to investigate safety, Pk and tolerability of a continuous daily dosing of the active drugs (at 3 different doses) in healthy participants.
• Masking: Double (Participant, Investigator)
• Masking Description: The study is double-blinded. Patients will be randomised to receive 1 of 3 doses of the Active IMP or a matching placebo.
• Primary Purpose: Other
• Official Title: A Randomised, Double-Blind, Placebo-Controlled, Exploratory Phase I Trial Assessing the Pharmacokinetic Profile, Safety and Tolerability of a Continuous Daily Dosing Regimen of Active IMP in Healthy Volunteers
• Actual Study Start Date: Sep 22, 2020
• Actual Primary Completion Date: Mar 9, 2021
• Actual Study Completion Date: Mar 9, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50mcg/kg (oral) Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Drug: Ivermectin; Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study
Experimental: 75mcg/kg (oral) Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Drug: Ivermectin; Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study
Experimental: 100mcg/kg (oral) Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28	Drug: Ivermectin; Ivermectin: Investigation of the safety, tolerability and the pharmacokinetic profile of the active IMP in an exploratory study
Placebo Comparator: Matching Placebo (oral) Placebo using tablets identical to the Active IMP	Drug: Placebo; Matching Placebo to the Active IMP.

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax]) [D1, D2 and D28]

   Maximum plasma concentration (Cmax)

2. Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax]) [D1, D2 and D28]

   Time to reach Cmax (Tmax)

3. Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr]) [D1, D2 and D28]

   area under the plasma concentration-time curve from zero to 24 hours (AUC0-24hr) concentration-time curve from zero to 24 hours (AUC0-24hr)

4. Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2]) [D28]

   apparent terminal half-life (t1/2)

Secondary Outcome Measures

1. Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs) [From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days.]

   Clinical safety data from adverse event (AE) reporting

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

Important Inclusion Criteria:

• Subject is male of any ethnic origin.

• Subject is aged between 18 to 45 years, inclusive.

• Subject has a body mass index (BMI) of 18.5 to 32.0 kg/m2, inclusive.

• Subject is ≥50 kg.

• Negative reverse transcription polymerase chain reaction (RT-PCR) Test for severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) at Screening and negative lateral flow immunoassay test for SARS-CoV-2 at Day -1.

• Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, neurological examinations, concomitant medication, vital signs, 12-lead ECG and clinical laboratory evaluations.

• Male subjects must use a condom during the study and for 3 months after their final dose of study medication, if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly effective contraception from first dosing until 3 months following final dosing.

Important Exclusion Criteria:

• Clinically relevant history of abnormal physical or mental health (defined as any subject requiring medical, psychological or pharmacotherapeutic intervention for mental illness) interfering with the study as determined by medical history and physical examinations obtained during Screening and Day -1 as judged by the Investigator (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder).

• Any other concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study as outlined in this Protocol, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.

• Evidence of previous SARS-CoV-2 infection from medical history.

• Ophthalmologic disorder (moderate and sever retina or optic nerve pathology; cataracts excluded).

• Subjects with a diagnosis of asthma or any other respiratory conditions.

• A neurologic disorder that may compromise blood brain barrier permeability (stroke within 90 days, brain tumour, multiple sclerosis, or other neuroinflammatory condition, a neurodegenerative disorder, epilepsy) or history of seizures.

• Positive test for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibody (anti-HCV) or human immunodeficiency virus I and II (anti-HIV I/II) at Screening.

• The subject has participated in a clinical study and has received a medication or a new chemical entity within 3 months or 5 half-lives (whichever is longer) prior to first dosing of current study medication.

• Use of any drugs that are known substrates of CYP3A4, P-glycoprotein (P-gp) from within 4 weeks of Screening and unable to refrain from them until the end of the study (e.g., rifampicin, quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat). Use of critical CYP3A4 substrate drugs such as warfarin or coumarin anticoagulants.

• Recent or expected microfilaricidal drug use, including ivermectin, or travel history to areas that are endemic for Loa loa or onchocerciasis (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan).

• Use of medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin, in the 30 days prior to Screening and unable to refrain from them until the end of the study.

• Consumption of any food or drinks containing cranberry, pomegranate, starfruit, grapefruit, pomelos, exotic citrus fruits or Seville oranges (including marmalade and juices made from these fruits) within 14 days prior to first dosing until the end of the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MAC Clinical Research Manchester (Early Phase Unit), Neuroscience Centre of Excellence	Manchester	Greater Mancherster	United Kingdom	M13 9NQ

Sponsors and Collaborators

• MedinCell S.A

Investigators

• Principal Investigator: Pui Man Leung, MD, MAC Clinical Research

Study Documents (Full-Text)

• Study Protocol - Dec 16, 2020
• Statistical Analysis Plan - Mar 8, 2021

More Information

Publications

None provided.

• Responsible Party: MedinCell S.A
• ClinicalTrials.gov Identifier: NCT04632706
• Other Study ID Numbers: mdc-TTG-CT-001
• First Posted: Nov 17, 2020
• Last Update Posted: Dec 27, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Ivermectin

Study Results

Participant Flow

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)	Matching Placebo (Oral)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28	Placebo tablets matching the Active Investigative Medicinal Product (IMP)
Period Title: Overall Study
STARTED	6	6	6	6
COMPLETED	6	6	5	6
NOT COMPLETED	0	0	1	0

Baseline Characteristics

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)	Matching Placebo (Oral)	Total
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28	Placebo tablets matching the Active IMP	Total of all reporting groups
Overall Participants	6	6	6	6	24
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	35.2	29.3	30.3	28.2	30.8
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%	0 0%	0 0%
Male	6 100%	6 100%	6 100%	6 100%	24 100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	6 100%	6 100%	6 100%	6 100%	24 100%
Body Mass Index (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	24.95	25.79	25.84	25.57	25.54

Outcome Measures

1. Primary Outcome

Title	Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax])
Description	Maximum plasma concentration (Cmax)
Time Frame	D1, D2 and D28

Outcome Measure Data

Analysis Population Description

All 18 participants on active IMP were eligible and analyzed for this endpoint. Number Analyzed per Row represents those with data available at each time point.

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
Measure Participants	6	6	6
Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups	57.2 (28.9)	41.7 (73.5)	46.5 (53.6)
Day 2 (first day on respective dose of active treatment)	22.3 (32.5)	24.4 (42.5)	33.2 (62.6)
Day 28 (last day of active treatment)	23.3 (52.8)	31.9 (27.6)	44.4 (68.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	50mcg/kg (Oral), 75mcg/kg (Oral), 100mcg/kg (Oral)
	Comments	Assessment of dose proportionality on D2 and D28
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.803
	Comments	If the p-value is more than 0.05 then dose proportionality can not be confirmed.
	Method	Mixed Models Analysis
	Comments

2. Primary Outcome

Title	Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax])
Description	Time to reach Cmax (Tmax)
Time Frame	D1, D2 and D28

Outcome Measure Data

Analysis Population Description

All 18 participants on active IMP were eligible and analyzed for this endpoint. Number Analyzed per Row represents those with data available at each time point.

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
Measure Participants	6	6	6
Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups	2.53 (36.8)	3.03 (50.6)	4.8 (47.2)
Day 2 (first day on respective dose of active treatment)	3.82 (36.7)	2.85 (38.8)	3.23 (34.5)
Day 28 (last day of active treatment)	2.83 (39.2)	3.03 (50.7)	3.03 (39.4)

3. Primary Outcome

Title	Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr])
Description	area under the plasma concentration-time curve from zero to 24 hours (AUC0-24hr) concentration-time curve from zero to 24 hours (AUC0-24hr)
Time Frame	D1, D2 and D28

Outcome Measure Data

Analysis Population Description

All 18 participants on active IMP were eligible and analyzed for this endpoint. Number Analyzed per Row represents those with data available at each time point.

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
Measure Participants	6	6	6
Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups	568 (33.6)	449 (62.0)	523 (60.5)
Day 2 (first day on respective dose of active treatment)	906 (31.4)	779 (53.1)	941 (59.0)
Day 28 (last day of active treatment)	1.06 (36.6)	1.5 (47.5)	1.75 (20.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	50mcg/kg (Oral), 75mcg/kg (Oral), 100mcg/kg (Oral)
	Comments	Assessment of dose proportionality on D2 and D28
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.689
	Comments	If the p-value is more than 0.05 then dose proportionality can not be confirmed.
	Method	Mixed Models Analysis
	Comments

4. Primary Outcome

Title	Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2])
Description	apparent terminal half-life (t1/2)
Time Frame	D28

Outcome Measure Data

Analysis Population Description

17 participants on active IMP were analysed for this endpoint. On day 21 one subject in the 100 μg/kg/day ivermectin treatment group was discontinued.

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28
Measure Participants	6	6	5
Geometric Mean (Geometric Coefficient of Variation) [hr]	102 (60.1)	99.2 (47.3)	127 (47.2)

5. Secondary Outcome

Title	Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs)
Description	Clinical safety data from adverse event (AE) reporting
Time Frame	From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days.

Outcome Measure Data

Analysis Population Description

All 24 included participants were eligible and analysed for this endpoint

Arm/Group Title	50mcg/kg (Oral)	75mcg/kg (Oral)	100mcg/kg (Oral)	Matching Placebo (Oral)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28	Placebo tablets matching the Active IMP
Measure Participants	6	6	6	6
Any TEAE	24	5	2	21
Any serious TEAE	0	0	0	0
Any TEAE leading to discontinuation - due to Study Medication-related TEAE	0	0	0	0
Any TEAE leading to discontinuation - other reason	0	0	1	0
TEAE - mild severity	24	5	2	20
TEAE - moderate severity	0	0	0	1
Causality (All TEAEs) - Not related	21	3	2	20
Causality (All TEAEs) - Related (possibly and probably)	3	2	0	1

Adverse Events

Time Frame	From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days
Arm/Group Title	50mcg/kg (Oral)		75mcg/kg (Oral)		100mcg/kg (Oral)		Matching Placebo (Oral)		Ivermectin Overall		Total (Ivermectin Overall and Placebo)
Arm/Group Description	Ivermectin loading dose of 200 mcg/kg followed by daily doses of 50mcg/kg from D2 to D28.		Ivermectin loading dose of 200 mcg/kg followed by daily doses of 75mcg/kg from D2 to D28.		Ivermectin loading dose of 200 mcg/kg followed by daily doses of 100mcg/kg from D2 to D28.		Placebo tablets matching the Active IMP		Ivermectin loading dose of 200 mcg/kg followed by daily doses of either 50, 75, or 100mcg/kg from D2 to D28.		All study participants
All Cause Mortality
	50mcg/kg (Oral)		75mcg/kg (Oral)		100mcg/kg (Oral)		Matching Placebo (Oral)		Ivermectin Overall		Total (Ivermectin Overall and Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/18 (0%)		0/24 (0%)
Serious Adverse Events
	50mcg/kg (Oral)		75mcg/kg (Oral)		100mcg/kg (Oral)		Matching Placebo (Oral)		Ivermectin Overall		Total (Ivermectin Overall and Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/18 (0%)		0/24 (0%)
Other (Not Including Serious) Adverse Events
	50mcg/kg (Oral)		75mcg/kg (Oral)		100mcg/kg (Oral)		Matching Placebo (Oral)		Ivermectin Overall		Total (Ivermectin Overall and Placebo)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100%)		3/6 (50%)		2/6 (33.3%)		6/6 (100%)		11/18 (61.1%)		17/24 (70.8%)
Cardiac disorders
Palpitations	1/6 (16.7%)	2	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	2/18 (11.1%)	3	2/24 (8.3%)	3
Gastrointestinal disorders
Diarrhoea	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Nausea	3/6 (50%)	4	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	3/18 (16.7%)	4	4/24 (16.7%)	5
Toothache	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
General disorders
Chest discomfort	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	2	0/18 (0%)	0	1/24 (4.2%)	2
Infections and infestations
Oral herpes	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Injury, poisoning and procedural complications
Back injury	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Burns first degree	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Exposure to communicable disease	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Joint injury	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Limb injury	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Investigations
Transaminases increased	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Metabolism and nutrition disorders
Decreased appetite	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Dehydration	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Musculoskeletal and connective tissue disorders
Muscle twitching	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Myalgia	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Neck pain	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Nervous system disorders
Dizziness	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	2/18 (11.1%)	2	3/24 (12.5%)	3
Headache	3/6 (50%)	5	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	4/18 (22.2%)	6	5/24 (20.8%)	7
Lethargy	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	2/6 (33.3%)	2	1/18 (5.6%)	1	3/24 (12.5%)	3
Paraesthesia	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Somnolence	2/6 (33.3%)	2	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/18 (11.1%)	2	2/24 (8.3%)	2
Respiratory, thoracic and mediastinal disorders
Cough	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Epistaxis	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/6 (33.3%)	2	0/18 (0%)	0	2/24 (8.3%)	2
Nasal congestion	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Oropharyngeal pain	2/6 (33.3%)	2	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	2/18 (11.1%)	2	2/24 (8.3%)	2
Rhinorrhoea	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Skin and subcutaneous tissue disorders
Eczema	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/18 (0%)	0	1/24 (4.2%)	1
Pruritus	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/18 (5.6%)	1	1/24 (4.2%)	1
Rash	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	2/18 (11.1%)	2	3/24 (12.5%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PI does not have the right to publish or otherwise present any results or data related to the study without an expressed written agreement from the Sponsor.