A Study of LY3016859 in Healthy Volunteers

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01545583
• Collaborator: (none)
• Enrollment: 56
• Location: 1
• Arms: 9
• Duration (Months): 5
• Patients Per Site Per Month: 11.1

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the safety and tolerability of LY3016859 administered as single doses, and to determine how long LY3016859 remains in the body

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: LY3016859 intravenous; Drug: Placebo intravenous; Drug: LY3016859 subcutaneous; Drug: Placebo subcutaneous	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 56 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Study of the Safety, Tolerability and Pharmacokinetics of LY3016859 After Single Intravenous and Subcutaneous Dosing in Healthy Volunteers
• Study Start Date: Apr 1, 2012
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo intravenous Placebo administered once intravenously	Drug: Placebo intravenous; Administered intravenously
Experimental: 0.1 milligram (mg) LY3016859 intravenous 0.1 mg LY3016859 administered once intravenously	Drug: LY3016859 intravenous; Administered intravenously
Experimental: 1 mg LY3016859 intravenous 1 mg LY3016859 administered once intravenously	Drug: LY3016859 intravenous; Administered intravenously
Experimental: 10 mg LY3016859 intravenous 10 mg LY3016859 administered once intravenously	Drug: LY3016859 intravenous; Administered intravenously
Experimental: 50 mg LY3016859 intravenous 50 mg LY3016859 administered once intravenously	Drug: LY3016859 intravenous; Administered intravenously
Experimental: 250 mg LY3016859 intravenous 250 mg LY3016859 administered once intravenously	Drug: LY3016859 intravenous; Administered intravenously
Experimental: 750 mg LY3016859 intravenous 750 mg LY3016859 administered once intravenously	Drug: LY3016859 intravenous; Administered intravenously
Placebo Comparator: Placebo subcutaneous Placebo administered once subcutaneously	Drug: Placebo subcutaneous; Administered subcutaneously
Experimental: 50 mg LY3016859 subcutaneous 50 mg LY3016859 administered once subcutaneously	Drug: LY3016859 subcutaneous; Administered subcutaneously

Outcome Measures

Primary Outcome Measures

1. Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE) [From baseline up to 8 weeks post dose]

   Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.

Secondary Outcome Measures

1. Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα) [Predose up to 8 weeks post dose]

2. Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin [Predose up to 8 weeks post dose]

3. Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859 [Predose up to 8 weeks post dose]

4. Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf) [Predose up to 8 weeks post dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy men and women of non-childbearing potential as determined by medical history and physical examination (PE), and:

• Men agree to use 2 medically accepted methods of contraception with all sexual partners during the study and for 90 days after the final dose

• Women are not of child-bearing potential due to surgical sterilization (at least 6 weeks after surgical bilateral oophorectomy with or without hysterectomy or at least 6 weeks after tubal ligation) confirmed by medical history, or post-menopause. Post-menopausal status will be defined as a woman 45 years of age or older with either 12 months of spontaneous amenorrhea, or 6-12 months of spontaneous amenorrhea combined with follicle stimulating hormone (FSH) greater than (>) 40 international units per liter (IU/L)

• Are reliable and are willing to make themselves available for the duration of the study, and are willing to follow site specific study procedures

• Must weigh greater than or equal to (≥) 50 kilograms (kg) at time of screening and dosing

• Have clinical laboratory test results within normal reference range for the investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator

• Have venous access sufficient to allow blood sampling as per the protocol

• Must be a non-smoker

Exclusion Criteria:

• Are currently enrolled in, or have discontinued within the last 60 days from a clinical trial involving an investigational drug that has not received regulatory approval for any indication, or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing

• Have previously completed or withdrawn from this study or any other study investigating LY3016859, and have previously received the investigational product

• Have a history or presence of medical illness including but not limited to any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric or neurological disease, or any clinically significant laboratory abnormality, that in the judgment of the investigator indicates a medical problem that would preclude study participation

• Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or have:

• Confirmed corrected QT interval using Fridericia's formula (QTcF) > 450 milliseconds (msec) for men and > 470 msec for women

• Bundle branch blocks or other conduction abnormalities other than mild first-degree atrio-ventricular block

• Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats

• History of unexplained syncope

• Family history of unexplained sudden death or sudden death due to long QT syndrome

• T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator

• Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies, hepatitis C and/or positive hepatitis C antibody, or Hepatitis B and/or positive Hepatitis B surface antigen

• Show use of any medication with potential to mask allergic response for example (e.g.) antihistamines, systemic glucocorticoids or antipyretic agents) within 3 days of dosing (Note: Acetaminophen or nonsteroidal analgesics for headache may be allowed as needed in the Investigator's judgment. The following medications are also specifically allowed in this study: vitamins at normal replacement doses, hormone replacement therapies e.g. estrogen, thyroid hormone), topical medications with limited systemic effects (e.g. eye drops, skin creams, vaginal antifungals, hemorrhoid preparations, etcetera (etc.), stable preventive therapies for hyperlipidemia and gastric acidity disorders)

• Have donated blood of more than 500 milliliters (mL) within the last month.

• Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol within 48 hours of entry into study and for the duration of the study [1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits]

• Have an abnormal blood pressure (sitting) defined as diastolic blood pressure (DBP) > 95 or less than (<) 50 millimeters of mercury (mmHg) and/or systolic blood pressure (SBP) > 150 or < 90 mmHg confirmed by at least 1 repeat measurement

• Have evidence of regular use of known drugs of abuse or show positive findings for such use on urinary drug screening

• Will donate blood or participate in another clinical trial within 3 months or 5 half-lives of study drug (whichever is longer) of receiving the last study drug administration

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.	London		United Kingdom	NW10 7EW

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern Time (UTC/GMT- 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT01545583
• Other Study ID Numbers: 14352; 2011-005596-17; I5V-MC-TGAA
• First Posted: Mar 7, 2012
• Last Update Posted: Jul 19, 2018
• Last Verified: Sep 1, 2017

Study Results

Participant Flow

Arm/Group Title	Placebo IV	Placebo SC	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC
Arm/Group Description	Placebo administered once intravenously (IV).	Placebo administered once subcutaneously (SC).	0.1 milligram (mg) LY3016859 administered once intravenously.	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously.
Period Title: Overall Study
STARTED	12	2	6	6	6	6	6	6	6
Received at Least 1 Dose of Study Drug	12	2	6	6	6	6	6	6	6
COMPLETED	12	2	6	6	6	6	6	6	6
NOT COMPLETED	0	0	0	0	0	0	0	0	0

Baseline Characteristics

Arm/Group Title	Placebo IV	Placebo SC	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC	Total
Arm/Group Description	Placebo administered once intravenously (IV).	Placebo administered once subcutaneously (SC).	0.1 milligram (mg) LY3016859 administered once intravenously.	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously.	Total of all reporting groups
Overall Participants	12	2	6	6	6	6	6	6	6	56
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	29.8 (9.19)	27.0 (11.31)	29.7 (8.48)	36.5 (9.71)	30.2 (8.59)	43.2 (17.42)	41.3 (17.25)	47.0 (14.68)	33.0 (11.68)	35.3 (13.02)
Sex: Female, Male (Count of Participants)
Female	1 8.3%	0 0%	0 0%	1 16.7%	0 0%	2 33.3%	1 16.7%	0 0%	0 0%	5 8.9%
Male	11 91.7%	2 100%	6 100%	5 83.3%	6 100%	4 66.7%	5 83.3%	6 100%	6 100%	51 91.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	2 33.3%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	2 3.6%
Not Hispanic or Latino	12 100%	2 100%	4 66.7%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	54 96.4%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	6 50%	0 0%	0 0%	2 33.3%	1 16.7%	2 33.3%	0 0%	1 16.7%	1 16.7%	13 23.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	3 25%	0 0%	0 0%	0 0%	1 16.7%	0 0%	1 16.7%	1 16.7%	1 16.7%	7 12.5%
White	3 25%	1 50%	5 83.3%	4 66.7%	2 33.3%	3 50%	5 83.3%	3 50%	4 66.7%	30 53.6%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	1 50%	1 16.7%	0 0%	2 33.3%	1 16.7%	0 0%	1 16.7%	0 0%	6 10.7%
Region of Enrollment (participants) [Number]
United Kingdom	12 100%	2 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	6 100%	56 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs) or Any Serious AEs (SAE)
Description	Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Time Frame	From baseline up to 8 weeks post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug.

Arm/Group Title	Placebo IV	Placebo SC	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC
Arm/Group Description	Placebo administered once intravenously (IV).	Placebo administered once subcutaneously (SC).	0.1 milligram (mg) LY3016859 administered once intravenously.	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously.
Measure Participants	12	2	6	6	6	6	6	6	6
TEAE	2 16.7%	0 0%	2 33.3%	3 50%	0 0%	0 0%	0 0%	1 16.7%	0 0%
SAE	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%	0 0%

2. Secondary Outcome

Title	Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Transforming Growth Factor Alpha (TGFα)
Time Frame	Predose up to 8 weeks post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had TGFα measurements.

Arm/Group Title	Placebo IV	Placebo SC	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC
Arm/Group Description	Placebo administered once intravenously (IV).	Placebo administered once subcutaneously (SC).	0.1 milligram (mg) LY3016859 administered once intravenously.	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously.
Measure Participants	12	2	6	6	6	6	6	6	6
Mean (Standard Deviation) [hour*nanograms/milliliter (h*ng/mL)]	41271 (109300.8)	8573 (5072.1)	2515 (2340.0)	4444 (4234.6)	9718 (9089.5)	4286 (2578.9)	8244 (6487.5)	12075 (17137.0)	10305 (7555.2)

3. Secondary Outcome

Title	Pharmacodynamics: Area Under the Concentration-Time Curve (AUC) of Serum Epiregulin
Time Frame	Predose up to 8 weeks post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had serum epiregulin measurements.

Arm/Group Title	Placebo IV	Placebo SC	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC
Arm/Group Description	Placebo administered once intravenously (IV).	Placebo administered once subcutaneously (SC).	0.1 milligram (mg) LY3016859 administered once intravenously.	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously.
Measure Participants	12	2	6	6	6	6	6	6	6
Mean (Standard Deviation) [hour*picograms/milliliter (h*pg/mL)]	349927 (118584.0)	331408 (52233.4)	280500 (65395.6)	296022 (94056.4)	405745 (76219.5)	379401 (59460.6)	697442 (229112.6)	2254733 (1035876.0)	474081 (280526.0)

4. Secondary Outcome

Title	Pharmacokinetics: Maximum Serum Concentration (Cmax) of LY3016859
Time Frame	Predose up to 8 weeks post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to estimate Cmax.

Arm/Group Title	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC
Arm/Group Description	0.1 milligram (mg) LY3016859 administered once intravenously (IV).	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously (SC).
Measure Participants	5	6	6	6	6	6	6
Mean (Standard Deviation) [nanograms/milliliter (ng/mL)]	36 (4.3)	399 (95.6)	3812 (718.3)	18467 (1882.2)	106967 (20038.0)	271167 (59650.4)	3748 (1550.8)

5. Secondary Outcome

Title	Pharmacokinetics: Area Under the Serum Concentration-Time Curve (AUC) of LY3016859 From Time Zero to Infinity (AUC0-inf)
Time Frame	Predose up to 8 weeks post dose

Outcome Measure Data

Analysis Population Description

All randomized participants who received at least one dose of study drug and had sufficient LY3016859 pharmacokinetic data to calculate AUC0-inf.

Arm/Group Title	0.1 mg LY3016859 IV	1 mg LY3016859 IV	10 mg LY3016859 IV	50 mg LY3016859 IV	250 mg LY3016859 IV	750 mg LY3016859 IV	50 mg LY3016859 SC
Arm/Group Description	0.1 milligram (mg) LY3016859 administered once intravenously (IV).	1 mg LY3016859 administered once intravenously.	10 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once intravenously.	250 mg LY3016859 administered once intravenously.	750 mg LY3016859 administered once intravenously.	50 mg LY3016859 administered once subcutaneously (SC).
Measure Participants	0	3	6	6	6	5	5
Mean (Standard Deviation) [hour*nanograms/milliliter (h*ng/mL)]	9967 (2375.4)	235759 (46760.1)	2769626 (516303.9)	23180633 (9009921.3)	81450520 (20101546.7)	1054034 (536160.4)

Adverse Events

Arm/Group Title	Placebo IV		Placebo SC		0.1 mg LY3016859 IV		1 mg LY3016859 IV		10 mg LY3016859 IV		50 mg LY3016859 IV		250 mg LY3016859 IV		750 mg LY3016859 IV		50 mg LY3016859 SC
Arm/Group Description	Placebo administered once intravenously (IV).		Placebo administered once subcutaneously (SC).		0.1 milligram (mg) LY3016859 administered once intravenously.		1 mg LY3016859 administered once intravenously.		10 mg LY3016859 administered once intravenously.		50 mg LY3016859 administered once intravenously.		250 mg LY3016859 administered once intravenously.		750 mg LY3016859 administered once intravenously.		50 mg LY3016859 administered once subcutaneously.
All Cause Mortality
	Placebo IV		Placebo SC		0.1 mg LY3016859 IV		1 mg LY3016859 IV		10 mg LY3016859 IV		50 mg LY3016859 IV		250 mg LY3016859 IV		750 mg LY3016859 IV		50 mg LY3016859 SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo IV		Placebo SC		0.1 mg LY3016859 IV		1 mg LY3016859 IV		10 mg LY3016859 IV		50 mg LY3016859 IV		250 mg LY3016859 IV		750 mg LY3016859 IV		50 mg LY3016859 SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	0/12 (0%)		0/2 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	Placebo IV		Placebo SC		0.1 mg LY3016859 IV		1 mg LY3016859 IV		10 mg LY3016859 IV		50 mg LY3016859 IV		250 mg LY3016859 IV		750 mg LY3016859 IV		50 mg LY3016859 SC
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	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	5/12 (41.7%)		1/2 (50%)		4/6 (66.7%)		3/6 (50%)		2/6 (33.3%)		2/6 (33.3%)		4/6 (66.7%)		3/6 (50%)		1/6 (16.7%)
Ear and labyrinth disorders
Ear pain	1/12 (8.3%)	1	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Vertigo	1/12 (8.3%)	1	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Eye disorders
Dry eyes	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Gastrointestinal disorders
Constipation	2/12 (16.7%)	3	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Dyspepsia	1/12 (8.3%)	1	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
General disorders
Feeling cold	0/12 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Feeling hot	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Immune system disorders
Seasonal allergy	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Infections and infestations
Folliculitis	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Rhinitis	0/12 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Injury, poisoning and procedural complications
Arthropod bite	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Musculoskeletal and connective tissue disorders
Back pain	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Muscle spasms	0/12 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Musculoskeletal pain	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Myalgia	1/12 (8.3%)	1	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Nervous system disorders
Dizziness	0/12 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Headache	5/12 (41.7%)	5	1/2 (50%)	1	0/6 (0%)	0	2/6 (33.3%)	2	1/6 (16.7%)	1	1/6 (16.7%)	1	2/6 (33.3%)	2	0/6 (0%)	0	0/6 (0%)	0
Lethargy	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Paraesthesia	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Psychiatric disorders
Depression	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1
Respiratory, thoracic and mediastinal disorders
Cough	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0
Nasal discomfort	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Oropharyngeal pain	1/12 (8.3%)	1	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Rhinitis allergic	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Rhinorrhoea	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Sneezing	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	2/6 (33.3%)	2	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Skin and subcutaneous tissue disorders
Dry skin	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Eczema	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0
Heat rash	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Pruritus	0/12 (0%)	0	0/2 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0
Rash maculo-papular	0/12 (0%)	0	0/2 (0%)	0	0/6 (0%)	0	1/6 (16.7%)	1	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0	0/6 (0%)	0

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.