Trial Outcomes & Findings for Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults (NCT NCT02151110)

NCT ID: NCT02151110

Last Updated: 2019-02-15

Results Overview

An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 59 participants
• Primary outcome timeframe: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit
• Results posted on: 2019-02-15

Participant Flow

Healthy adult male and female participants were recruited in a blinded manner. The study was conducted at one site in the United Kingdom.

A total of 259 participants were screened of which 200 participants were considered screen failures and the remaining 59 participants were randomized. Out of which, 56 participants were treated

Participant milestones

Measure	Placebo Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Overall Study STARTED	12	2	2	8	8	8	8	8
Overall Study COMPLETED	12	2	2	8	8	8	8	5
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	3

Reasons for withdrawal

Measure	Placebo Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	0	0	0	0	2

Baseline Characteristics

Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults

Baseline characteristics by cohort

Measure	Placebo n=12 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=2 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg n=8 Participants Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.	TOTAL n=56 Participants Total of all reporting groups
Age, Continuous	33.3 Years STANDARD_DEVIATION 8.9 • n=5 Participants	27.5 Years STANDARD_DEVIATION 4.9 • n=7 Participants	26.0 Years STANDARD_DEVIATION 1.4 • n=5 Participants	27.8 Years STANDARD_DEVIATION 12.3 • n=4 Participants	28.1 Years STANDARD_DEVIATION 10.1 • n=21 Participants	38.4 Years STANDARD_DEVIATION 9.3 • n=8 Participants	33.3 Years STANDARD_DEVIATION 9.2 • n=8 Participants	32.0 Years STANDARD_DEVIATION 9.8 • n=24 Participants	31.8 Years STANDARD_DEVIATION 9.8 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	8 Participants n=8 Participants	8 Participants n=8 Participants	8 Participants n=24 Participants	56 Participants n=42 Participants

PRIMARY outcome

Timeframe: The start of study drug administration (Day 1) to the follow-up period (Day 113) or early discontinuation visit

Population: As-treated Population: All participants who received any study drug were included in this population

An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.

Outcome measures

Measure	Placebo n=12 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=2 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg n=8 Participants Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TEAEs	10 Participants	1 Participants	1 Participants	5 Participants	8 Participants	3 Participants	5 Participants	7 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) TESAEs	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The maximum observed plasma concentration (Cmax) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Maximum Observed Plasma Concentration (Cmax) of MEDI4920	1.00 microgram per milliliter (µg/mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	4.46 microgram per milliliter (µg/mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	7.97 microgram per milliliter (µg/mL) Standard Deviation 0.873	23.6 microgram per milliliter (µg/mL) Standard Deviation 2.76	85.6 microgram per milliliter (µg/mL) Standard Deviation 17.6	289 microgram per milliliter (µg/mL) Standard Deviation 58.1	960 microgram per milliliter (µg/mL) Standard Deviation 126	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-last) of MEDI4920	3.64 microgram*day per milliliter (µg*d/mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	19.3 microgram*day per milliliter (µg*d/mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	53.4 microgram*day per milliliter (µg*d/mL) Standard Deviation 10.9	151 microgram*day per milliliter (µg*d/mL) Standard Deviation 20.2	581 microgram*day per milliliter (µg*d/mL) Standard Deviation 38.3	2090 microgram*day per milliliter (µg*d/mL) Standard Deviation 394	6640 microgram*day per milliliter (µg*d/mL) Standard Deviation 553	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The area under the plasma concentration-time curve from time zero to infinity (AUC 0-inf) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of MEDI4920	4.60 microgram*day per milliliter (µg*d/mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	20.5 microgram*day per milliliter (µg*d/mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	54.8 microgram*day per milliliter (µg*d/mL) Standard Deviation 11.0	152 microgram*day per milliliter (µg*d/mL) Standard Deviation 20.2	583 microgram*day per milliliter (µg*d/mL) Standard Deviation 37.8	2090 microgram*day per milliliter (µg*d/mL) Standard Deviation 394	6640 microgram*day per milliliter (µg*d/mL) Standard Deviation 547	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The AUC (0-infinity)/D is the area under concentration-time curve extrapolated to infinity postdose normalized by MEDI4920 dose. The AUC (0-infinity)/D was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Dose-normalized AUC0-inf (AUC0-infinity/D) of MEDI4920	1.53 µg*d/mL/mg Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	2.05 µg*d/mL/mg Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	1.83 µg*d/mL/mg Standard Deviation 0.366	1.52 µg*d/mL/mg Standard Deviation 0.202	1.94 µg*d/mL/mg Standard Deviation 0.126	2.09 µg*d/mL/mg Standard Deviation 0.394	2.21 µg*d/mL/mg Standard Deviation 0.182	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The terminal elimination half-life (t1/2) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Terminal Elimination Half Life (t1/2) of MEDI4920	4.41 Day(s) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	5.35 Day(s) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	5.31 Day(s) Standard Deviation 2.30	5.49 Day(s) Standard Deviation 1.59	8.86 Day(s) Standard Deviation 1.60	9.68 Day(s) Standard Deviation 1.25	10.1 Day(s) Standard Deviation 1.87	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The systemic clearance (CL) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Systemic Clearance (CL) of MEDI4920	661 milliliter per day (mL/day) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	487 milliliter per day (mL/day) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	564 milliliter per day (mL/day) Standard Deviation 96.8	668 milliliter per day (mL/day) Standard Deviation 90.4	517 milliliter per day (mL/day) Standard Deviation 33.5	494 milliliter per day (mL/day) Standard Deviation 102	454 milliliter per day (mL/day) Standard Deviation 37.9	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The volume of distribution at steady-state (Vss) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Volume of Distribution at Steady-state (Vss) of MEDI4920	3980 milliliter (mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	3290 milliliter (mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	4280 milliliter (mL) Standard Deviation 684	5560 milliliter (mL) Standard Deviation 806	5180 milliliter (mL) Standard Deviation 811	5450 milliliter (mL) Standard Deviation 1150	4900 milliliter (mL) Standard Deviation 715	—

SECONDARY outcome

Timeframe: Pre-infusion, at the middle of the infusion, post-infusion (5 minutes, and 2, 6, and 12 hours) on Day 1; Days 2, 3, 5, 8, 15, 22, 29, 43, 57, 85, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population

The volume of distribution based on terminal phase (Vz) was estimated based on the plasma concentrations of MEDI4920. Standard deviation was calculated only if number of participants were more than or equal to 3.

Outcome measures

Measure	Placebo n=2 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=8 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Volume of Distribution Based on Terminal Phase (Vz) of MEDI4920	4130 milliliter (mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	3760 milliliter (mL) Standard Deviation NA Not calculated; Standard deviation was only calculated if N \>= 3.	4080 milliliter (mL) Standard Deviation 1090	5230 milliliter (mL) Standard Deviation 1360	6590 milliliter (mL) Standard Deviation 1160	6880 milliliter (mL) Standard Deviation 1520	6600 milliliter (mL) Standard Deviation 1190	—

SECONDARY outcome

Timeframe: Baseline (pre-infusion on Day 1) and post-baseline Days 15, 29, 57, and 113 or early discontinuation visit, whichever occurred first

Population: As-treated Population.

Plasma samples were collected for assessment of anti-drug antibodies (ADA) against MEDI4920. The incidence of positive serum antibodies to MEDI4920 are presented.

Outcome measures

Measure	Placebo n=12 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=2 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg n=8 Participants Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Percentage of Participants Positive for Anti-drug Antibodies (ADA) Baseline ADA positive	16.7 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants
Percentage of Participants Positive for Anti-drug Antibodies (ADA) Post-baseline ADA positive	8.3 Percentage of participants	50 Percentage of participants	100 Percentage of participants	100 Percentage of participants	87.5 Percentage of participants	37.5 Percentage of participants	37.5 Percentage of participants	12.5 Percentage of participants

SECONDARY outcome

Timeframe: Day 43

Population: As-treated Population.

The T-cell dependent antibody response (TDAR) assay measures the immune response (ie, antibody production) to an introduced antigen, keyhole limpet hemocyanin (KLH). The KLH is a potent immunostimulating protein with an extensive history of safe and effective use in vaccine development and immunological research. TDAR was evaluated by measuring anti-KLH IgG titers at a time point consistent with the expected timing for antibody responses following immunization. The primary time point for the analysis of the TDAR to KLH was Day 43. The data was presented for geometric mean ratio (MEDI4920/placebo) estimated from the dose response model.

Outcome measures

Measure	Placebo n=11 Participants Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 Participants Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=2 Participants Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 Participants Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=7 Participants Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 Participants Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 Participants Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg n=8 Participants Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
T-cell Dependent Antibody Response (TDAR) Measured by Anti-keyhole Limpet Hemocyanin Immunoglobulin G (Anti-KLH IgG) Concentration	NA nanogram per milliliter (ng/mL) Geometric mean ratio and 95% CI were not estimated for placebo, as the estimation was performed using the dose response model which only applies to participants who received MEDI4920.	0.99 nanogram per milliliter (ng/mL) Interval 0.96 to 1.01	0.96 nanogram per milliliter (ng/mL) Interval 0.89 to 1.03	0.88 nanogram per milliliter (ng/mL) Interval 0.72 to 1.08	0.68 nanogram per milliliter (ng/mL) Interval 0.41 to 1.14	0.42 nanogram per milliliter (ng/mL) Interval 0.18 to 0.97	0.22 nanogram per milliliter (ng/mL) Interval 0.1 to 0.47	0.14 nanogram per milliliter (ng/mL) Interval 0.06 to 0.32

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

MEDI4920 3 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MEDI4920 10 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

MEDI4920 30 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MEDI4920 100 mg

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

MEDI4920 300 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

MEDI4920 1000 mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

MEDI4920 3000 mg

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=12 participants at risk Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 participants at risk Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=2 participants at risk Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 participants at risk Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 participants at risk Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 participants at risk Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 participants at risk Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg n=8 participants at risk Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Injury, poisoning and procedural complications Tibia fracture	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).

Other adverse events

Measure	Placebo n=12 participants at risk Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.	MEDI4920 3 mg n=2 participants at risk Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.	MEDI4920 10 mg n=2 participants at risk Participants received single IV dose of MEDI4920 10 mg infused on Day 1.	MEDI4920 30 mg n=8 participants at risk Participants received single IV dose of MEDI4920 30 mg infused on Day 1.	MEDI4920 100 mg n=8 participants at risk Participants received single IV dose of MEDI4920 100 mg infused on Day 1.	MEDI4920 300 mg n=8 participants at risk Participants received single IV dose of MEDI4920 300 mg infused on Day 1.	MEDI4920 1000 mg n=8 participants at risk Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.	MEDI4920 3000 mg n=8 participants at risk Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
Ear and labyrinth disorders Ear discomfort	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	25.0% 2/8 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Eye disorders Blepharitis	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Eye disorders Eye inflammation	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Eye disorders Ocular hyperaemia	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Eye disorders Vision blurred	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Gastrointestinal disorders Abdominal pain	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Gastrointestinal disorders Diarrhoea	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	25.0% 2/8 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Gastrointestinal disorders Nausea	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Gastrointestinal disorders Toothache	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Gastrointestinal disorders Vomiting	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
General disorders Fatigue	8.3% 1/12 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
General disorders Feeling hot	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Immune system disorders Seasonal allergy	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Infections and infestations Herpes zoster	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Infections and infestations Hordeolum	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Infections and infestations Influenza	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Infections and infestations Nasopharyngitis	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	62.5% 5/8 • Number of events 5 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	25.0% 2/8 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Infections and infestations Oral herpes	8.3% 1/12 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	25.0% 2/8 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Infections and infestations Rash pustular	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Injury, poisoning and procedural complications Joint dislocation	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Metabolism and nutrition disorders Decreased appetite	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Nervous system disorders Dizziness	16.7% 2/12 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Nervous system disorders Headache	33.3% 4/12 • Number of events 4 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	25.0% 2/8 • Number of events 3 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	37.5% 3/8 • Number of events 3 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Nervous system disorders Memory impairment	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Nervous system disorders Migraine	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Nervous system disorders Paraesthesia	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Product Issues Device failure	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Respiratory, thoracic and mediastinal disorders Cough	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Respiratory, thoracic and mediastinal disorders Nasal congestion	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	50.0% 1/2 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	8.3% 1/12 • Number of events 2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Skin and subcutaneous tissue disorders Eczema	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/12 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	12.5% 1/8 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).
Skin and subcutaneous tissue disorders Night sweats	8.3% 1/12 • Number of events 1 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/2 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).	0.00% 0/8 • Adverse events were collected from time of signature of informed consent, throughout the treatment period, and the follow-up period (through Day 113 or early discontinuation visit).

Additional Information

David Howe, MBChB, MD, MRCOG

MedImmune LLC

Phone: +44 (0) 1223 895980

Email: information.center@astrazenea.com

Results disclosure agreements

• Principal investigator is a sponsor employee MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
• Publication restrictions are in place

Restriction type: OTHER